薬学および生命科学における研究開発の国際ジャーナル

抽象的な

VALIDATION OF ANALYTICAL METHODS - STRATEGIES & SINGFICANCE

Shashi daksh1, Anju goyal, Chakshu k. pandiya

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.