Methods For Determinations Of Drugs, Drug Release & Its Impurities - Dhananjay Mane - Bog

Determination of exact quantity of drug in the drug formulation requires accurate and robust analytical method. Analytical method development and validation plays an important role in the drug discovery, development, and quality control of pharmaceutical products. The method should be simple and fast so that it can be adopted by any laboratory easily. The methods which are used in analysis of stability studies for assay and related substances should be stability indicating analytical methods. The peaks of solutes and impurities under determination should be pure and hence peak purity in the methods for determination of assay and related impurities should be passed. The developed methods need to be validated as per current regulatory guidelines. All the validated methods should pass the acceptance criteria as per industrial and regulatory norms.Due to these high expectations, pharma industry is suffering, since many of the firms are using regular conventional techniques to determine the drug quantities and their impurities. To keep the pace with rapid improvement in quality standards of drugs all over the world and keeping in view the essential requirements.