Bioanalytical methods for assessment of drugs is a quintessential part of pre-clinical as well as clinical studies because of its pivotal role in understanding various parameters about a drug like its safety, toxicity, formulation optimization, pharmacokinetic parameters, etc. Bioanalytical methods are widely used to quantitate drugs and their metabolites in physiological matrices and these methods could be applied in study areas of clinical and nonclinical pharmacology/ toxicology. In recent times, LC-MS/MS has become the most dominant instrument for bioanalytical analysis of drugs due to its various advantages. However, many researchers have also developed bioanalytical method by using HPLC with UV as detection system. These methods have been validated as per the guidelines and hence have the applicability in optimum conditions. This review mainly discusses the sample extraction, method development, process optimization and validation parameters on HPLC with focus on the utility of reversed phase column and UV as detection system in a bioanalytical method development.
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