Development and Validation of Analytical Instrumental Method for Pharmaceutical Products
Kalyani A. Gudadhe1*, Mukund G. Tawar2
1.Department of Quality Assurance, Faculty of Pharmacy, P.R. Pote Patil college of Pharmacy-444604
2.Department of Pharmaceutics, Faculty of
Pharmacy, P.R.Pote Patil college of Pharmacy-444604
Development, and production of pharmaceutical products. The authorized test methods that result from HPLC, UV processes are used by quality control laboratories to make sure the Identity, characteristics, purity, potency, and performance of drug products. Analytical methods development ought to be validated to give reliable data for regulatory submissions. This review gives information regarding various stages involved in development and validation of analytical methods like UV, HPLC. Rapid increase in pharmaceutical industries and production of drug in various parts of the world has brought a rise in demand for new analytical techniques in the pharmaceutical industries. As a result, analytical method development has developed into the basic activity of analysis. Recent development in analytical methods has been result from the advancement of analytical instruments.
Keywords : High performance liquid chromatography (HPLC); (LOQ) UV-visible spectrophotometer. limit of detection (LOD); Limit of quantitation