Abstract

A REVIEW ON HPLC METHOD DEVELOPMENT AND VALIDATION

Kalpesh V. Khairnar*, Aishwarya P. Mahamuni, Anusaya V. Babalsure, Satish V. Udbale and Chandrawadan V. Panchal

Abstract

HPLC is the most widely used separation method in contemporary pharmaceutical and biomedical analysis, Due to its very effective separations and often high detection sensitivity. Due to the HPLC method's numerous benefits, including its speed, specificity, accuracy, precision, and ease of automation, the majority of medications in multi-component dosage forms can be examined using this technique. The development and validation of HPLC procedures are crucial to novel discoveries, the creation of pharmaceutical medications, and numerous other human and animal investigations. To compare a defined characteristic of the drug substance or drug product to predetermined acceptance criteria for that characteristic, an analytical technique is designed. This review provides details on the numerous steps that go into developing and validating an HPLC technique. According to ICH Guidelines, validating an HPLC technique include testing for system appropriateness as well as accuracy, precision, specificity, linearity, range and limit of detection, limit of quantification, robustness, and other performance characteristics.

Keywords: HPLC, Method development, Validation, Analysis.