Abstract

A NOVEL UV- SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF SIMVASTATIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Rashmi T.*, Karthik K., Samudratha S., Athira P., Chandini S.

ABSTRACT

A simple, accurate and precise Area under curve spectroscopic method was developed and validated for the estimation of Simvastatin in bulk and Pharmaceutical dosage forms and has an absorption maximum between 236-246 nm in 0.1 M HCl. The Linearity was found to be in the concentration range of 2-12 μg/ml and the correlation coefficient was found to be 0.9999 and it has showed good linearity, reproducibility, precision in this concentration range. The regression equation was found to be Y = 0.0485 X + 0.0006. The % recovery values were found to be within 99.15 - 99.94 % showed that the method was accurate. The LOD and LOQ were found to be 0.018871 and 0.18871 μg/ml, respectively. The % RSD values were less than 2. The method has been validated according to ICH guidelines for linearity, accuracy, precision, robustness, ruggedness. Limit of detection and limit of quantitation. Proposed method was successfully applied for the quantitative estimation of Simvastatin in bulk and pharmaceutical dosage form.

Keywords: Simvastatin, Area under curve Spectroscopy, 0.1M HCl, accuracy.