What is HPLC Method Development, Validation, and Analysis?

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 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 short cut 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.

HPLC Method Development and Analysis during Drug Discovery, Preclinical, and Clinical Phases

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.

HPLC Method Development and Analysis by NorthEast BioLab

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

Why Choose NorthEast BioLab for your HPLC Method Development and Analysis?

Our client-centric approach along with 15+ 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.