Novel Analytical Method Development and Validation for Estimation of Clinical Important Simvastatin in Bulk and Pharmaceutical Dosage Form by UV Spectrometric Method Using Phosphate Buffer Solubility

Author(s): Suvarna G. Bhokare* and R.P. Marathe

According to World Health Organization statistics, more than 16 million people die of cardiovasculardisease each year, and 7.2 million deaths in 2001 were caused by heart disease. By the year 2020, approximately 25 million deaths annually worldwide are expected from cardiovascular disease, and almost half of those deaths (11.1 million) will be from coronary heart disease. Simvastatin, an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, is administered in the form of lactone prodrug. Simvastatin lowers plasma cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-CoA reductase and found most effective for the treatment of cardiovascular disease. The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV-Visible spectrophotometric method for the estimation of simvastatin in bulk and pharmaceutical formulation. The solvent used throughout the experiment was methanol and water. Absorption maximum of the drug was found to be 238nm in phosphate buffer pH 7.4. Beer’s law was obeyed in the range of 02-200μg/ml. The method was shown linear in the mentioned concentrations having line equation y = 0.021x + 0.063 with correlation coefficient R2 of 0.977. The recovery values for simvastatin ranged from 99.95%-100.21%.The percent relative standard deviation (%RSD) of interday and intraday precision range was found below 2%. The percent relative standard deviation of robustness and ruggedness of the method was found within the prescribed limit as per recommended guideline of ICH. Hence, proposed method was precise, accurate and cost effective. This method could be applicable for quanti-tative determination of the bulk drug as well as dosage formulation.


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