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
ABSTRACT
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