Abstract

RP-HPLC METHOD FOR DETERMINATION OF SIMVASTATIN IN BULK AND TABLET FORMULATION

Vidya D.*, Lalitha N., Mubeen G. and Sharanabasava Navali

ABSTRACT

Simvastatin[1] is a well-known cholesterol-lowering agent belonging to the statin class, the most frequently prescribed and efficient drugs used to treat hypercholesterolemia and coronary heart disease. A reverse phase HPLC method was developed and validated for quantitative determination of Simvastatin. Simvastatin was determined using a Phenomenex C18(250mm×4.6mm×5μm), isocratic mobile phase of acetonitrile: Ammonium acetate buffer(5mM) at pH4.6, at a flow rate of 1ml/min. The analytes were monitored at 238nm and retention time was found to be 5.55min. The peak obtained was symmetrical with tailing factor less than 2 and theoretical plates more than 2000. The developed HPLC method showed good linearity (R2 = 0.999). The intra- and inter-day precision was less than 2%, accuracy for three different levels was found to be 99.75%w/w-100.66%w/w. LOD and LOQ were 0.153 and 1.22 μg/ml respectively. The method was validated in accordance with ICH guidelines Q2 (R1)[2] and was found to be Specific, Accurate, Precise, Robust and can be successfully applied for routine analysis of Simvastatin bulk and pharmaceutical dosage form.

Keywords: RP-HPLC, Acetonitrile (ACN), Simvastatin (SIM).