A Review on Novel Analytical Method Development and Validation by RP-HPLC Method

Abstract

A simple, precise, accurate, specific and RP-HPLC method was developed for determination of drug in
pharmaceutical formulation. Analytical method development and validation play important roles in the
drug discovery, drug development and manufacture of pharmaceuticals. It involves detection of the purity
and toxicity of a drug substance. The present study focuses on the various steps, parameters involved in
HPLC condition. It can be adopted apparently for routine quality control study of research and formulation
tests. This article mainly focuses on the optimization of HPLC conditions and other important aspects
during method of process development and validation of drug substances. The main objective of this review
is to elaborate the novel analytical techniques utilized in method development and validation of varied
pharmaceuticals because it is extremely much significant for the steadiness, efficacy and quality of the
drug product. Various validation parameters like accuracy, specificity, precision, linearity, LOD, LOQ,
ruggedness, and robustness also are listed concerning ICH Guidelines. Validation is extremely much useful
for the standard control and quality assurance of pharmaceuticals and therefore the safety of patients.