Development and Validation of UV/Visible Spectrophotometric Method for the Estimation of Simavastatin in Bulk and Pharmaceutical Formulations

R. Sai Bharath*, A. Aswini, J. Arshiya, J. Nikhil Yadav, G. Siddartha,Paul Richards M

Simavastatin is an antihyperlipedemic drug used in the treatment of atherosclerosis a cardiovascular disorder A simple, sensitive, accurate and reproducible UV/visible spectrophotometric method was developed for the determination of Simavastatin in bulk and pharmaceutical dosage forms. The solvent used was distilled water and wavelength corresponding to maximum absorbance for the drug was found at 238 nm. Drug obeyed beer’s law in the concentration range of 10 – 60µg/ml. with a correlation coefficient of 0.999. The linear regression equation obtained was y=0.0565x+0.0249, where y is the absorbance and x is the concentration of the pure drug solution. The method was validated for several parameters such as Linearity, Accuracy, Precision and Robustness as per the ICH guidelines. The % recovery value which is close to 100% indicates reproducibility of the method and absence of interference of the excepients present in the formulation. The authors conclude that the proposed spectrophotometric method for the estimation of Simavastatin can be used for routine analysis of Simavastatin in bulk as well as in tablet dosage form.