sales@nebiolab.com Follow Up On Email
(203) 361 3780 Follow Up On Phone
Agile Bioanalytical Services CRO
  • Expertise
    • All Expertise
    • Mass Spectrometry (LC-MS)
      • Mass Spectrometry Services
      • HPLC Lab Services
    • Meso Scale Discovery Assay
    • ELISA Assay
      • Luminex Multiplex Assay
    • qPCR Analysis, dPCR Assay
    • LI-COR Odyssey (WB, ICW)
  • Services
    • All Services
    • Pharmacokinetics (PK) Study
      • Toxicology (Tox) Study
      • Dose Formulation Analysis
      • PK PD Analysis
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • ADME Studies
      • Bioequivalence and Bioavailability Studies
    • ADA Assay, Neutralizing Antibody Assay
    • Cytokine Analysis, Biomarker Assay
      • Biomarker Assay List
    • Cell-Based Assays
      • Mechanism of Action (MOA) Studies
      • Cytotoxicity Assay
      • Biochemical Assay
    • Bioanalytical Assay Validation
  • Solutions
    • All Solutions
    • Method Development, Validation, And Transfer
      • Method Validation
      • Method Development
      • Method Transfer
    • Clinical CRO
      • Central Lab Services
    • GLP Laboratory
      • Bioanalysis
      • Non-GLP Testing
    • Preclinical CRO
    • Analytical Testing
      • Discovery and Research
      • Analytical Quantitation
      • Cosmetic Testing
  • About Us
    • About Us
    • Overview
    • Why Us?
    • Values
    • Leadership
    • Process
    • Quality and Compliance
    • Facility and Equipment
    • Therapeutic Areas
    • Partners
    • Careers
      • GLP Quality Assurance Manager, Bioanalytical Lab
      • Sr. Scientist, ELISA Immunoassay Bioanalysis
      • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
      • Associate Scientist, Central Laboratory Services
      • Sr. Scientist – Pharmacokinetics (PK) Studies
      • Content Manager, Scientific and Regulatory Writing
  • Resources
    • Learning Center
    • Blog
    • Case Study
    • Video Brochures
    • News and Events
    • Testimonials
    • Contact Us
  • Request Quote
Agile Bioanalytical Services CRO Request Quote

Expertise

  • All Expertise
    • Mass Spectrometry (LC-MS)
      • Mass Spectrometry Services
      • HPLC Lab Services
    • Meso Scale Discovery Assay
      • ELISA Assay
        • Luminex Multiplex Assay
      • qPCR Analysis, dPCR Assay
        • LI-COR Odyssey (WB, ICW)

          Services

          • All Services
            • Pharmacokinetics (PK) Study
              • Toxicology (Tox) Study
              • Dose Formulation Analysis
              • PK PD Analysis
              • Drug Metabolism and Pharmacokinetics (DMPK)
              • ADME Studies
              • Bioequivalence and Bioavailability Studies
            • ADA Assay, Neutralizing Antibody Assay
              • Cytokine Analysis, Biomarker Assay
                • Biomarker Assay List
              • Cell-Based Assays
                • Mechanism of Action (MOA) Studies
                • Cytotoxicity Assay
                • Biochemical Assay
              • Bioanalytical Assay Validation

                Solutions

                • All Solutions
                  • Method Development, Validation, And Transfer
                    • Method Validation
                    • Method Development
                    • Method Transfer
                  • Clinical CRO
                    • Central Lab Services
                  • GLP Laboratory
                    • Bioanalysis
                    • Non-GLP Testing
                  • Preclinical CRO
                    • Analytical Testing
                      • Discovery and Research
                      • Analytical Quantitation
                      • Cosmetic Testing

                    About Us

                    • About Us
                      • Overview
                        • Why Us?
                          • Values
                            • Leadership
                              • Process
                                • Quality and Compliance
                                  • Facility and Equipment
                                    • Therapeutic Areas
                                      • Partners
                                        • Careers
                                          • GLP Quality Assurance Manager, Bioanalytical Lab
                                          • Sr. Scientist, ELISA Immunoassay Bioanalysis
                                          • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
                                          • Associate Scientist, Central Laboratory Services
                                          • Sr. Scientist - Pharmacokinetics (PK) Studies
                                          • Content Manager, Scientific and Regulatory Writing

                                        Resources

                                        • Learning Center
                                          • Blog
                                            • Case Study
                                              • Video Brochures
                                                • News and Events
                                                  • Testimonials
                                                    • Contact Us

                                                      Request Quote

                                                        Contact Us

                                                        NorthEast BioLab Logo Agile Bioanalysis Services CRO
                                                        Request Quote Contact Us
                                                        • Home
                                                        • HPLC Lab Services, HPLC Testing Services, HPLC Analysis Services

                                                        Reliable HPLC Lab Analysis, HPLC Testing Services For Over 20 Years!

                                                        • FDA Audited HPLC Lab For Your Dose Formulation And Stability Testing
                                                        • Rapid HPLC Method Development And GLP Method Validation
                                                        • High-Value, Tailored HPLC Testing Services For Small Molecules, Peptides, Oligonucleotides, etc
                                                        • HPLC Analysis Services At Industry-Leading Turnaround

                                                        Regulated And Inspected By:

                                                        Good Laboratory Practice for Nonclinical Laboratory StudiesFood and Drug Administration (FDA)

                                                        Provide Your Bioanalysis Study Details

                                                        We Will Respond Within 1 Business Day

                                                        Lab
                                                        Click below for answers to your HPLC Method Development Validation questions -
                                                        • What is HPLC Method Development, Validation, and Analysis?
                                                          What is HPLC Method Development, Validation, and Analysis?
                                                        • When is HPLC Method Development, Validation, and Analysis used?
                                                          When is HPLC Method Development, Validation, and Analysis used?
                                                        • Which HPLC Method Development, Validation, and Analysis do we offer?
                                                          Which HPLC Method Development, Validation, and Analysis do we offer?
                                                        • Why Choose us for HPLC Method Development, Validation, and Analysis?
                                                          Why Choose us for HPLC Method Development, Validation, and Analysis?

                                                        FDA Audited HPLC Method And Analysis Lab Services!

                                                        • HPLC Method Development And Validation As Per FDA Guidance For Chromatographic Assay (CC)
                                                        • On-going HPLC-UV Analysis Services For Drug Compound And Metabolite Screening During Early Discovery
                                                        • Preclinical/Clinical HPLC Testing For Proprietary or Commercial Reference Compounds In Biological Matrices
                                                        • Tailor-Made, High-Value HPLC Lab Services For Various Small Molecules Formulations In Vehicle
                                                        SPEAK TO OUR SCIENTISTS

                                                        What Is HPLC Method Development, Validation, and Analysis?

                                                        Foolproof HPLC Method Development, Validation, and Analysis for Reliable Peaks and Bioanalytical Data

                                                        High Performance Liquid Chromatography (HPLC) method development, validation, and analysis is one of the most widely used techniques for drug testing in formulations and biological fluids. Usually, the first step in HPLC method development is to review existing information given substantial research has already been published on this topic. Next, it is imperative to select a proper HPLC column that can provide a sharp peak with a reasonable retention time. In this step, a neat solution of the analyte is chromatographed using an appropriate column. There are countless choices of HPLC columns from different vendors, and the selection of an adequate column can itself be challenging. Afterward, we should select a suitable mobile phase for sound separation of analyte from impurities or endogenous material. Closer to the end, we deliberate over the detection technique for HPLC method development. This step, however, has become somewhat routine given the mass spectrometer has emerged as a popular choice for HPLC analysis due to its highly selective nature. Alternative detection modes require revisiting method development and further troubleshooting. Finally, careful sample preparation is also essential and must be reviewed thoroughly during HPLC method development. Often analysts take a shortcut for HPLC sample preparation and rely on the mass spectrometer for selective analyte detection. This practice, however, sometimes does not work out successfully due to ion suppression and a variety of other reasons. In summary, High-performance liquid chromatography (HPLC) Analysis is an analytical chemistry technique to separate, detect, and quantitate different drugs and metabolites within various formulations, vehicles, and biological matrices. For assay reproducibility, HPLC Method Development relies on the right combination of pumps, analytical columns and pre-columns, mobile phase, and autosampler conditions. HPLC Method Validation ensures proper assay selectivity, sensitivity, and reproducibility.

                                                        Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround

                                                        Connect With Us For A Reference Call With Them!

                                                        VP, Bioanalytical Development

                                                        NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

                                                        VP, Biomarker Development 

                                                        We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

                                                        Executive Director, Pharmacokinetics

                                                        We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

                                                        President & CSO, Biotech

                                                        We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.

                                                        Sr. Associate Dir., Clinical Trials

                                                        We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

                                                        Co-Founder, Biotech & University PI

                                                        NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.

                                                        VP, PK PD Analysis

                                                        NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

                                                        Head, Bioanalytical Development

                                                        NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

                                                        Sr. Dir., Bioanalytical Development & QC

                                                        NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

                                                        SVP Quality & Compliance, Biotech

                                                        We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.

                                                        Director, PK

                                                        We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

                                                        VP, Head of Clinical Operations

                                                        Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

                                                        Executive Director, Drug Research

                                                        NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.

                                                        Dir., Bioequivalence Testing

                                                        Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

                                                        Head, PK

                                                        This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.

                                                        VP, Development Operations

                                                        As a small company, our vendors are key members of our project teams. The scientists at NorthEast BioLab are technical experts, who produce high-quality data, on-time, and on-budget.

                                                        Ready To Take The First Step, Today?

                                                        Explore Our HPLC Assay Development, Validation, And Testing Services Lab CRO!
                                                        SPEAK TO OUR SCIENTISTS

                                                        When Is HPLC Method Development, Validation, And Analysis Used?

                                                        HPLC Method Development, Validation, and Analysis: From Drug Discovery to Clinical Trials

                                                        HPLC method development is required at each phase of drug R&D, starting from the early discovery phase. During this stage, the HPLC method can be developed utilizing a generic protocol as the drug is being analyzed at a higher concentration and only semi-quantitative values are needed. Naturally, this fit-for-purpose approach helps lower the HPLC test cost significantly during early discovery studies. As the drug advances in the next phase, however, it becomes crucial to optimize the method and make it more reproducible. HPLC method validation becomes necessary when Tox studies are planned for preparing IND application filing. These methods developed properly can be promptly validated. Therefore, we must prioritize robust HPLC method development and analysis even during the earlier stages. This way, the methods used in preclinical phase can be seamlessly transferred to the clinical programs and would not require extensive HPLC method development and validation.

                                                        Complete Guide On LC-MS: Working, Analysis & Methods

                                                        Mass spectrometry is a widely used procedure observed as having outstanding sensitivity. Triple-quadrupole mass spectrometry (MS/MS) offers additional benefits due to its selectivity. In mass spectrometry analysis, it is essential to isolate….

                                                        Read More at our Learning Center

                                                        Which HPLC Method Development, Validation, and Analysis Do We Offer?

                                                        HPLC Method Development, Validation, and Analysis by NorthEast BioLab

                                                        NorthEast BioLab provides HPLC method development, validation, and Analysis services for various stages – from early discovery to clinicaldevelopment phase.

                                                        Drug Discovery

                                                        During the drug discovery phase, our expert scientists collaborate to select and optimize the HPLC method that would be utilized for your analysis. HPLC methods help analyze drug concentration in biological fluids to evaluate ADME (absorption, distribution, metabolism, and excretion) profile of the drug. The drug discovery phase also involves pharmacology and toxicology assessments of the drug compounds.

                                                        Preclinical Studies

                                                        HPLC method development and validation are essential in this phase as the preclinical studies aim to generate and document the safety, pharmacokinetics, toxicokinetics, and potency parameters for the drug compounds.

                                                        Clinical Studies

                                                        Upon successful IND filing, the clinical phase of drug development is initiated and the HPLC method developed completed earlier is further refined for the analysis of drugs and metabolites in biofluids as per the pharmacokinetic studies.

                                                        Registered And Inspected By Various Regulatory Agencies

                                                        Why Choose Us For HPLC Method Development, Validation, and Analysis?

                                                        Long-Term Partnership for HPLC Method Development, Validation, and Analysis Assay and Beyond

                                                        NorthEast BioLab has state-of-the-art PerkinElmer equipment coupled to spectrophotometric or mass spectrometry detection as well as a deep bench of talent skilled at swift and dependable HPLC Method Development, Validation, and Analysis.

                                                        Our client-centric approach along with 20+ years rich experience in HPLC method development and analysis enables us to contribute expert guidance for your drug development program. We constantly realign ourselves to your evolving drug discovery and development goals – flexibility for iterative research or expectation for a swifter turnaround – as your drug compounds progress onwards. Therefore, our HPLC method development, validation, and sample analysis protocols are designed to cater to your dynamic needs.

                                                        Driven by founding values, our primary focus is making your drug product a great success through our outstanding HPLC method development offering. Our scientists and analysts are genuinely centered on productive long-term collaboration with your team. Finally, we play for the long term and do it right by ensuring the full integrity of our in-house processes, even as we continue trying to lower the resource intensity and HPLC test cost of your studies at every stage.

                                                        Questions On Our HPLC Assay Development, Validation, And Testing Lab CRO Services?

                                                        Our Experienced Scientists Are Ready To Help You, Today!
                                                        SPEAK TO OUR SCIENTISTS

                                                        Related FAQs

                                                        Answers to additional HPLC Method Development, Validation, and Analysis questions popular among our potential clients.

                                                        What are the major applications of HPLC testing?

                                                        High-performance liquid chromatography is the technique that can separate, identify, and quantify components in a mixture. HPLC testing is the most powerful chromatography technique essential to most laboratories across the globe. There are many applications for HPLC analysis but not limited to water purification, detection of impurities in pharmaceutical industries, Pre-concentration of trace components, ligand-exchange chromatography, Ion-exchange chromatography of proteins, and high pH anion-exchange chromatography of carbohydrates. HPCL assay is also used in method development, method validation, and study testing.

                                                        What are the advantages/disadvantages of HPLC analysis?

                                                        There are many steps involved, the hplc assay is largely automated and the process is therefore highly reproducible and precise. The limitations of hplc include lower sensitivity and possible intereference from other peaks. Because of the speed of HPLC analysis and its dependence on different polarities of the compounds, multiple compounds with similar structures and polarities can elute off the chromatography apparatus at the same time or nearly the same time. HPLC analysis has a high operating cost and increased run time as compared to UPLC.

                                                        What are the major components of HPLC method validation?

                                                        HPLC method validation is a recognized and efficient way to determine the suitability of the assay method to provide relevant data to confirm that the process or the HPLC testing gives acceptable and reliable results within the scope of the process. The most widely applied HPLC method validation characteristics are accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, robustness, and stability of analytical resolutions.

                                                        What is the difference between HPLC and UPLC?

                                                        High-Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) are both liquid chromatography procedures used to separate and detect the different components found in complex mixtures. However, UPLC operates at higher pressures (~15,000 psi) and permits for smaller particle sizes in columns, while HPLC operates at lower pressures (max <6000 psi). UPLC shows higher analyte resolution and sensitivity, and uses less solvents, and shorter run times. In contrast, HPLC analysis consumes more solvent with less sample throughput, but the hardware costs less.

                                                        What types of analytes are compatible with HPLC assays?

                                                        The HPLC analysis of small molecules is most often performed in reversed-phase separation mode. Hydrophilic interaction chromatography (HILIC) and normal-phase chromatography are also suitable for separating polar compounds, with HILIC being the preferred method. Ion chromatography can also separate ionic compounds, ion-exchange separation modes, and inorganic anions or cations.

                                                        What types of HPLC testing services are offered in a HPLC lab?

                                                        High-performance liquid chromatography (HPLC) testing is an analytical chemistry procedure to separate, detect, and quantify drugs and their metabolites within various formulations, vehicles, and biological matrices. HPLC lab offered actives quantitation, additive analysis, extractable and leachable, assay and impurity analysis, identification, including contaminant analysis and quantitation.

                                                        What is system suitability test in hplc analysis?

                                                        The System Suitability Test (SST) is used to verify that an analytical method was suitable for its intended purpose of the day for the analysis was done. It is an essential parameter to ensure the quality of the process for correct measurements. Each SST is specific to a method with predefined acceptance criteria for certain parameters, e.g., absorbance values between 0.2 and 1.0 for a photometric content determination method or some resolution factors for chromatographic techniques. System suitability proves that the system is working flawlessly before the analysis on HPLC or any other system, and it is required to be done before every sample analysis.

                                                        How to develop hplc method for reverse phase?

                                                        The applicable procedures of ultra−high-performance liquid chromatography (UHPLC) are the analysis of assay and organic impurities, related substances, drug products, or raw material of pharmaceuticals or degradation products of a drug substance or intermediate. A suitable method is developed only after assessing chromatography’s main and critical separation parameters (examples for UPLC-HPLC are wavelength, a choice of diluent, stationary phase, detector, flow rate, column temperature, solvent system, injection volume, and elution mode, Etc.). The development of the analytical method shows that the developed analytical approach is appropriate for its proposed use for the quantitative assessment of the targeted analyte present in therapeutic drugs. And it typically plays a vital part in the development and making of pharmaceutical medications.

                                                        What makes hplc testing best for dose formulation analysis?

                                                        Dose confirmation study for formulation samples is a significant part of any compelling GLP study and is mandatory by the United States Food and Drug Administration (USFDA) for formulations dosed in toxicology studies. We provide high-quality, preclinical dose formulation analysis for GLP and non-GLP studies to ensure your study starts on the right path. NorthEast Biolab (NEBA) has significant experience in all aspects of dose formulation analysis. Methods utilize either UV/Vis or Fluorescence detectors, appropriate for your protein or small molecule. In addition, NEBA has substantial infrastructure and decades of expertise in qualitative and quantitative separations utilizing HPLC mass spectrometry detection of peptide drugs. Solid, semisolid, and liquid formulations of pharmaceutical leads are one essential step in drug development. Methods are optimized to confirm the API concentration in your dosing formulation, as well as solution uniformity and stability. In addition, if stereoisomers are part of the formulation, we have years of chiral experience at your service.

                                                        Why do we use hplc testing to determine stability in dosing vehicle formulation?

                                                        In HPLC testing, determination of dosing vehicle stability of the product for its formulation, the impact of its pharmaceutical components, the manufacturing and processing conditions, the impact of the container and closure, packaging components, storage environments, estimated conditions of shipping, light, temperature, and humidity. Stability testing is utilized to control if the quality of a drug substance or drug product is transformed over time by numerous environmental factors, such as temperature, light, and humidity. Stability testing is determined to indicate how the quality of a drug substance or drug product differs with time under the influence of various environmental factors such as humidity, light, and temperature, and also determines a re-test period for the drug material or shelf life for the drug.

                                                        What are the key drivers for HPLC method development?

                                                        HPLC method development shows that the developed chromatography method is suitable for its intended use in the development and manufacturing of pharmaceutical drug ingredients and drug products. The fundamental separation techniques and principles involved in the analytical method development using the HPLC and UPLC are a selection of chromatography mode, detector, column (stationary phase), mobile phase, organic modifiers, ion-pair reagents, flow rate, solvent delivery system (elution mode), diluent, methods of extraction, samples to be used, experimentation to finalize the procedure, selection of test concentration and injection volume, forced degradation studies (stress resting), evaluation of stress testing Mass balance study, finalization of wavelengths, stability of the solution, system suitability, robustness of the method, relative response factor, quantification methods.

                                                        What are the criteria required for suitable quantitation during a HPLC study?

                                                        Quantitative results in high-performance liquid chromatography (HPLC) are usually based on calibration with standards and peak-area measurement. A distinctive method to determine the absolute number of moles of a compound from peak area measurements using HPLC with a UV–vis detector has been proposed.

                                                        Explore More Expertise

                                                        • Mass Spectrometry Services Mass Spectrometry
                                                          Services
                                                        • HPLC Lab Services HPLC Lab
                                                          Services
                                                        • Luminex Multiplex Assay Luminex Multiplex
                                                          Assay

                                                        Expertise

                                                        • Mass Spectrometry (LC-MS)
                                                        • Meso Scale Discovery Assay
                                                        • ELISA Assay
                                                        • qPCR Analysis, dPCR Assay
                                                        • LI-COR Odyssey (WB, ICW)

                                                        Services

                                                        • Pharmacokinetics (PK) Study
                                                        • ADA Assay, Neutralizing Antibody Assay
                                                        • Cytokine Analysis, Biomarker Assay
                                                        • Cell-Based Assay
                                                        • Bioanalytical Assay Validation

                                                        Solutions

                                                        • Method Development, Validation, And Transfer
                                                        • Clinical CRO
                                                        • GLP Laboratory
                                                        • Preclinical CRO
                                                        • Analytical Testing

                                                        About Us

                                                        • Overview
                                                        • Why Us?
                                                        • Values
                                                        • Leadership
                                                        • Process
                                                        • Quality and Compliance
                                                        • Facility and Equipment
                                                        • Therapeutic Areas
                                                        • Partners
                                                        • Careers

                                                        Resources

                                                        • Learning Center
                                                        • Blog
                                                        • Case Study
                                                        • Video Brochures
                                                        • News and Events
                                                        • Testimonials
                                                        • Contact Us
                                                        NorthEast BioLab Logo

                                                        35 Worth Ave, Hamden, CT 06518

                                                        sales@nebiolab.comFollow Up On Email
                                                        (203) 361 3780Follow Up On Phone

                                                        Contact A Scientist With Your Bioanalytical Study Details

                                                        We Will Respond Within 1 Business Day

                                                        • Good Laboratory Practice for Nonclinical Laboratory Studies
                                                        • Food and Drug Administration (FDA)
                                                        • United States Drug Enforcement Administration
                                                        • Connecticut State Department of Consumer Protection
                                                        • Privacy Policy
                                                        • Terms of Use
                                                        • Sitemap
                                                        © 2019 - 2025, NorthEast BioAnalytical Laboratories LLC. All rights reserved.

                                                        Before you go! Get
                                                        your FREE Download:

                                                        Top 7 Hidden Pitfalls to your Bioanalytical Milestones

                                                        Step by step guide on how to accelerate your drug approval

                                                        • Addressing Main Constraints
                                                        • Research Best Practices
                                                        • The Economic Advantage
                                                        • Critical Decision Marketing Mode Easy
                                                        • Legal Documentation Checklist
                                                        We won’t share your email, ever, See our privacy policy

                                                        No thanks, I don’t need to improve my drug approval process