alexa Abstract | Validated First Order Derivative Spectroscopic Method for the Determination of Cinitapride and Omeprazole in Bulk and Pharmaceutical Dosage Form.


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Research Article Open Access

Abstract

A simple, accurate, precise and sensitive First order derivative spectrophotometric method was developed for the estimation of Cinitapride and Omeprazole in bulk and pharmaceutical dosage forms. The estimation of Cinitapride and Omeprazole were carried out at 254.6 nm (Zero Crossing Point of Omeprazole) and 236.0 nm (Zero Crossing Point of Cinitapride) respectively. The method was found to be linear and obeys Beer’s law in the concentration range of 1.5-15 μg/ml (R2=0.9998) and 10-50 μg/ml (R2=0.9996) respectively. The developed method was validated according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The LODs (Limit of detection) were found to be 0.3440 and 0.6029 for Cinitapride and omeprazole respectively and LOQs (Limit of quantification) were found to be 0.7515 and 1.4331 for Cinitapride and omeprazole respectively. The accuracy was found to be 99.61-101.35 and 101.01-101.66 for Cinitapride and omeprazole respectively. The % assay was found to be 98.5- 100.70 % for Cinitapride and 99.20-100.50 % for Omeprazole. Thus the proposed method can be successfully applied for the estimation of Cinitapride and Omeprazole in bulk and pharmaceutical dosage forms.

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Author(s): Jagdish Jadav, Parul Parmar, Smita Talaviya, Sagar Solanki, Jignesh Patel, Mandev Patel

Keywords

Cinitapride, first order derivative spectroscopy, ICH guidelines, omeprazole, validation., Pharmaceutical Sciences

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