Abstract

UPDATED REVIEW ON ANALYTICAL METHOD VALIDATION

Santosh Gutthe*, Pritam Jain, Vishal Vyavhare, and Nilesh Patil

ABSTRACT

The top objective of any pharmaceutical industry is to produce products of necessary characteristic and quality reliably, in a cost-effective manner. Development of a method is essential for discovery, development, and evaluation of medicines in the pharmaceutical formulation. The main aim of this review article was to check the development and validation of the procedure employed for the medication from the starting of the formulation to the complete commercial batch of product. At the point when an analytical technique is applied to produce outcomes for the quality of medicine associated samples, it is necessary that the outcomes are reliable. In the pharmaceutical industry, validation policy is documented for how to perform Validation, types of validation and validation policy are Complied with the necessities of good manufacturing practice (GMP) regulations Validation is very important for the effective running of the pharmaceutical firms. The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. 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: Validation, Precision, Accuracy, Robustness.