Abstract

HPLC: A MODERN APPROACH OF DEVELOPMENT AND VALIDATION

Pawan Tiwari* and B. K. Singh

Abstract

High performance liquid chromatography is the dominant analytical technique which is Proficient to separate, detect and quantify various drugs and its related degradants. HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method.A number of chromatographic parameters were evaluated in order to optimize the method. An appropriate mobile phase, column, column temperature, wavelength and gradient must be found that affords suitable compatibility and stability of drug as well as degradants and impurities. In this review provide information regarding various stages involved in development and validation of HPLC method. Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness and system suitability testing.

Keywords: HPLC, Method development, Validation.