Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION BY HPLC

Anusaya V. Babalsure*, Kalpesh V. Khairnar, Satish V. Udbale, Ajim A. Shaikh, Chandrawadan V. Panchal

Abstract

The most popular separation method for identifying, sorting, and measuring pharmaceuticals is HPLC. Several chromatographic parameters, including as sample pretreatment, mobile phase selection, column selection, and detector selection, were examined in order to optimise the procedure. The development, optimisation, and validation of methods are covered in this article. The HPLC method can be used to analyse the majority of pharmaceuticals in multicomponent dosage forms due to its benefits including speed, specificity, accuracy, precision, and ease of automation. In the discovery, development, and production of new drugs as well as several other human and animal investigations, HPLC technique development and validation are essential. To make sure that analytical methods are appropriate for their intended use, validation of these methods is necessary during the development and production of pharmaceuticals. Pharmaceutical industry should have a general validation policy that specifies how validation will be done in order to comply with GMP criteria. The improvement of HPLC conditions is the main topic of this paper.

Keywords: HPLC, Method Development, Validation, Analysis.