Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ATORVASTATIN CALCIUM BULK AND PHARMACEUTICAL FORMULATIONS

J.N.Suresh Kumar, Ch.Narendra Babu*, T.Dhanalakshmi, K.Florence,M.Sita Ramanjaneyulu, N.Sambasivanaik

ABSTRACT

Atorvastatin Calcium is hypolipidemic agent. In the present study, a simple, sensitive, rapid and economic and specific UVSpectrophotometric method has been developed and validated for the Atorvastatin Calcium in bulk and pharmaceutical dosage forms. The Atorvastatin Calcium stock solutions are prepared in methanol. The method of analysis is derivative spectroscopy to eliminate spectral interference by measuring absorbance at 247nm for Atorvastatin Calcium respectively. The Atorvastatin are linear in concentration range of 0-25μg/ml respectively. The absorption maxima was determined with 10μg/ml by scanning in the range of 200-400nm. The method was validation in terms of linearity, accuracy, range, precision, robustness, LOD and LOQ, system suitability, stability of analytical solution. Results of analysis were validated statistically. Percentage recovery studies are in the range of 99.92% to 99.58%. The LOD and LOQ of Atorvastatin were 0.998μg/ml and 3.025μg/ml respectively. From that it was observed that is no interference of blank, excipients during the estimation of drug in formulation. This shows the adaptability in pharmaceutical dosage forms.

Keywords: Atorvastatin, method development, validation, spectrophotometer.