ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR EVALUATING THE STABILITY PARAMETERS FOR THE SIMULTANEOUS ESTIMATION OF CLOPIDOGREL BISULPHATE AND OMEPRAZOLE USING RP-HPLC

A simple, sensitive, accurate and specific stability-indicating high-performance liquid chromatographic method was developed and validated for the simultaneous estimation of clopidogrel bisulphate and omeprazole in bulk. Extensive testing of clopidogrel bisulphate and omeprazole in different stress conditions were carried out as per the ICH guidelines Q1A (R2) Clopidogrel bisulphate and omeprazole was exposed to various stress conditions like oxidation, hydrolysis, photolysis and neutral decomposition. Clopidogrel bisulphate, which was found to degrade considerably in acidic and photo conditions, was found to be stable in alkaline and neutral conditions, whereas omeprazole was found to be degrading in alkaline, oxidative and photo conditions, but stable in acidic and neutral condition. Apart from the formation of minor degraded products under accelerated conditions, the drugs were reasonably stable in solid state. A good linear relationship over the concentration range of 50-500μg/mL was shown. Validation of the method was carried out as per the ICH guidelines. The method developed was found to be specific, selective, precise and accurate. Clopidogrel bisulphate showed degradation in 5M hydrochloric acid at 80oC, in 3% hydrogen peroxide for 5min the drug showed around 35% of degradation, when exposed to sunlight for 15 min, forming around 25-30% of degradation products. Omeprazole showed 15-18% degradation in alkaline and photo condition.Statistical analysis shows that the method is reproducible and selective for the estimation of clopidogrel bisulphate and omeprazole in dosage form.