Validation of Analytical Procedures-A Review

Abstract

The development of analytical method is important during the process of drug discovery, release to market and development, culminating in market approval. The method development, optimization and validation of the drug product from the development stage of the formulation to commercial batch of product is essential. Method development for the finished product or in process tests and sample preparation drug product is to provide practical approaches for determining selectivity, specificity, limit of detection, limit of quantitation, linearity, range, accuracy, precision, recovery solution stability, ruggedness, robustness etc. This review article explains about the strategy and importance of validation of analytical methods.