Strategic Approaches of Controlling Variables in RP-HPLC Method Development and Validation: A Review

Abstract

High Performance Liquid chromatography is the principal technique in accessing the drug, its various impurities and drug related degradants that can form on synthesis or storage in pharmaceutical products. It results in highly efficient separations and in most cases provides high detection sensitivity. 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. Separation of components in a mixture is based on their interaction between a stationary and a mobile phase based on the properties such as polarity, electric charge (for ionic compounds), pH, functional groups and size of the molecule. Before starting method development there should be good understanding of the chemical structure, polarity. pH, pKa, molecular spectral absorbance electric charges(ionic compounds) of the molecule. 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.