A REVIEW: METHOD DEVELOPMENT AND VALIDATION

Lakhotra Surinder*, Sethi Reeta, Singh Gurcharan and Sindhi Megha

ABSTRACT

Now days, there are various strategies of high pressure liquid chromatography method development and validation. This review describes method, optimization and validation of high pressure liquid chromatography. Method development depends on chemical structure of the molecules, synthetic route, solubility, polarity, pH and pKa values, and functional group activity. Validation of high pressure liquid chromatography method as per ICH guidelines coves all the performance characteristics of validation like accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and system suitability testing. Most of the drugs in multi component dosage forms can be analyzed by high pressure liquid chromatography method because of the several merits that is rapidity, specificity, accuracy, and ease of automation in this method.

Keywords: Method Development, Validation, linearity, precession, column, mobile phase, stationary phase.