A STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF SIMVASTATIN AND NIACIN IN A COMBINED DOSAGE FORM
Keywords:Simvastatin, Niacin, RP-HPLC, Stability, Validation
Objective: To develop a simple, selective and rapid stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method and validate as per ICH guidelines for simultaneous determination of simvastatin and niacin in a combined dosage form.
Methods: The chromatographic separation of the two cholesterol lowering drugs were achieved using Inertsil CN (5 Âµm, 250 mm x 4.6 mm i. d. column), maintained at 30 Â°C throughout the analysis. The drugs were separated in isocratic elution mode with a mobile phase of 0.1% acetic acid buffer-methanol (50:50, v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 237 nm using a UV-PDA detector.
Results: The linearity and range for niacin and simvastatin were 0.05 to 0.150 mg/mL (R2> 0.9999) and 0.004 to 0.012 mg/mL (R2> 0.9992), respectively. Mean recoveries observed for niacin and simvastatin were 99.36% and 99.93%, respectively. The precision of the method obtained was 99.66% for niacin and 99.34% for simvastatin with a relative standard deviation less than 2%. The lower degree of % RSD that was obtained for intermediate precision has proved that the method is robust and rugged.
Conclusion: A simple and rapid stability-indicating RP-HPLC method was developed and validated for simultaneous determination of niacin and simvastatin in a combined dosage form and hence, it can be used in the quality control analysis of an active pharmaceutical ingredient and pharmaceutical dosage form.
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