Validated UV Method Development for the Simultaneous Estimation of Rabeprazole sodium and Cinitapride in Tablets


Volume :

3

Issue :

1

Abstract :

Current research attempts to develop simple, cost effective, and time saving, validated UV spectrophotometric method for the simultaneous estimation of Rabeprazole (RPZ) and Cinitapride (CTP) in tablet formulations by simultaneous equation method. The sampling wavelengths for RPZ and CTP are 284.5 nm and 267 nm respectively. Assay results showed 10.008 mg of RPZ and 2.974 mg of CTP were found in the tablet dosage form. The method was validated as per ICH guidelines. Linearity was obtained in the concentration range of 3-8 μg/mL for RPZ and 2-7 μg/mL for CTP. The %RSD for intraday and interday variations of RPZ was found to be 0.183±0.002 and 0.317±0.001 respectively. An intraday and interday variation of CTP was found to be 0.194±0.002 and 0.298±0.001 respectively. In both cases values were within the acceptance limit of < 2%. The mean percent recovery for RPZ and CTP were found to be 98.57 % and 99.43 % respectively, within the acceptance limit of 98% to 102%. From the high recovery values (> 98%) it can be inferred that the method is free from the interference of excipients used in the formulation. Based on the results obtained the proposed method can be regarded as simple, accurate, precise, reliable and cost effective which can be employed for routine quality control of RPZ and CTP in combined tablet dosage forms.
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