DEVELOPMENT AND VALIDATION OF REVERSED PHASE HPLC METHOD FOR ESTIMATION OF SIMVASTATIN IN PHARMACEUTICAL DOSAGE FORM

摘要

A simple, accurate rapid and precise RP-HPLC method has been developed and validated for determination of simvastatin in bulk drug. The RP-HPLC separation was achieved on Promosil C-18, (250 mm, 4.6 mm, 5μm) using mobile phase buffer: methanol ph 6.8 (96: 4 v/v) at flow rate of 1.0 ml/min at ambient temperature. The retention times were 9.546 min. for simvastatin. Calibration plots were linear over the concentration range 1-50μg/ml. Quantification was achieved with photodiode array detection at 254 nm over the concentration range of 1-50 μg/ml. The method was validated statistically and applied successfully for the determination of simvastatin. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for the routine determination of simvastatin in bulk drug.