k. Surendra*, SK. Karishma, G. Obulesu, M. Naveena
Rao’s College of Pharmacy, Chemudugunta, Venkatachalam, Nellore, Andhra Pradesh-524320
A B S T R A C T
Pharmaceutical analysis plays a very prominent role in quality assurance as well as quality control of bulk drugs and pharmaceutical formulations, of which analytical method development & validation is the basic activity. Analytical techniques are developed and validated for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, etc. These methods are used in quality control laboratories to ensure the identity, purity, safety, efficacy and performance of drug products. The main objective of this paper is to review the method development and validation of the method for the drug product, its strategy and their parameters as per ICH guidelines. It is essential to employ well-characterized and fully validated analytical methods to yield reliable result while analyzing the formulation or in-process products. Method development for the interested component in finished product or in process tests and the sample preparation of drug product and to provide practical approaches for determining selectivity, specificity, limit of detection, limit of quantitation, linearity, range accuracy, precision, recovery solution stability, ruggedness, and robustness of liquid chromatographic methods to support the Routine, in process and stability analysis.
Keywords: Quality control, Method development, Method Validation, ICH guidelines, Validation parameters, Analytical techniques