抽象的

Review on Analytical Method Development and Validation.

Review on Analytical Method Development and Validation.

Analytical methods development must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for quality control release, testing of stability samples, testing of reference materials and to provide data to support specifications.Analytical method followed by process of establishing evidence that provides a high degree of assurance and is an important process in the drug discovery. Although the drug shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of the drug. This review gives ideas about various methods to check the stability of drug and various validation parameters as per various regulatory authorities.