A Comprehensive Overview on Development and Validation of Stability Indicating HPLC Method for Quantification of Dolutegravir Sodium in Bulk as Well as Pharmaceutical Dosage Form

Abstract

Pharmaceutical industry deals with manufacturing, quality control and quality assurance of the bulk products as well as formulations. Analytical method development and validation are two major components of the pharmaceutical industry which are helpful in drug discovery, development and manufacturing process. Method development is a process designed based on various factors to evaluate the identity, quality, purity, and potency of the drug substances and drug products. However, Method validation is set of parameter which proves the authenticity and suitability of developed method. Validation parameters include specificity, accuracy, precision, linearity, limit of detection, limit of quantification, range, ruggedness and robustness. Forced degradation study also plays a vital role in drug development process. It provides information regarding degradation products present in any drug compound, degradation pathways, intrinsic stability of the drug molecule and validate stability indicating analytical methods. Today, due to increase in the production of drugs in the pharmaceutical industries, development of new analytical techniques has become necessary. Validation and Forced degradation study both are performed according to the regulatory guidelines such as International Council for Harmonisation (ICH). This article emphasizes on method development and validation and also provides an overview on stability indicating analytical method development and validation of dolutegravir sodium in pharmaceutical dosage form.