STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF EZETIMIBE & SIMVASTATIN IN TABLET DOSAGE FORM BY RP-HPLC
Keywords:
Ezetimibe, Simvastatin, RP-HPLCAbstract
ABSTRACT A simple, sensitive, specific and economic chromatographic method was developed through a Sunfire C18 (250) column , Mobile phase used was Acetonitrile: Phosphate buffer (60:40%), at the flow rate of 1.8ml/min, Ezetimibe & Simvastatin were eluted at acceptable retention times of 2.34 and 7.35 minutes respectively with good resolution by monitoring UVdetection at 225nm .Throughout the separation the drugs were stable, the studies were carried out by attempting deliberate degradation of the sample with exposure to stress conditions like acidic (1M HCl), alkaline (1M NaOH), 105OC Heat, Oxidizing agents (H2O2) and Water. This method was validated as per ICH-Q2 (R1) guidelines and met the regulatory requirements for specificity, selectivity, accuracy and stability. This method was fast, reliable and stable for the accurate determination of Ezetimibe & Simvastatin in formulation by RP-HPLC.
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