Bioanalytical Method Development and Validation by HPLC: A Review

The development of selective, sensitive and reliable bioanalytical methods for the quantitative evaluation of drugs and their metabolites in biological matrices is crucial for the successful drug development. The data obtained from these methods is required in the pharmacokinetic and toxicokinetic studies of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The results of animal toxicokinetic studies and of human clinical trials, including bioavailability and bioequivalence studies requiring pharmacokinetic evaluation are used to make critical decisions supporting the safety and efficacy of a drug. Therefore, it is of paramount importance that the developed bioanalytical methods are well designed, adequately validated and documented to a satisfactory standard to apply in drug analysis in order to obtain reliable results. High pressure liquid chromatography is a versatile analytical tool useful in identification and quantitative estimation of low concentration of drugs and metabolites in biological matrices. So it is advantageous to develop and validate bioanalytical HPLC method for low dose drugs. This article reviews current progress in HPLC based bioanalytical method development and validation of different drugs. So, far drugs like Anti malarials, Omeprazole, Clofarabine, Palonosetron HCl, etc have been analyzed bioanalytically.