Abstract

A COMPREHENSIVE REVIEW OF METHOD DEVELOPMENT BY HPLC

Puneet Narula* and Bikash Pal2

Abstract

Aim: Chromatography is the backbone of the separation techniques. High Pressure Liquid Chromatography (HPLC) is currently being used in almost every research laboratory and pharmaceutical industry to detect, separate, and quantify the drug. To develop a method, several chromatographic parameters needs to be optimized, like sample pretreatment, choosing mobile phase, column, and detector selection. HPLC plays an important role in the discovery, development, manufacture of pharmaceutical drugs, and various studies related to humans and animals. Method development also depends on the physicochemical properties of the molecule, solubility, polarity, pH, pKa value, and functional group activity. Objective: The objective of this article is to review the method development process of a HPLC method. A validated analytical method ensures that it provides consistent, reliable, and accurate data. So these methods are essential to ensure that products with optimum quality are released for the market. Validation of the HPLC method as per ICH (International Council for Harmonization) Guidelines covers all the parameters of validation, like Accuracy, precision, specificity, linearity, range, and limit of detection, the limit of quantification, robustness, and system suitability testing. Conclusion: A general and very simple approach for the HPLC method development for the separation of compounds was discussed. Knowledge of the physiochemical properties of the primary compound is of utmost importance prior to the any HPLC method development.

Keywords: Analytical Techniques, HPLC Method, HPLC Parameters, Method Development, Method Optimization.