Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

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Abstract

Analytical Method Development and Validation for Simultaneous Estimation of Cinitapride Hydrogen Tartrate and Pantoprazole Sodium in Pharmaceutical Dosage Form by RP-HPLC

Author(s): Sravanthi Macharla, Ravindar Bairam

The aim of the research is method development and validation of Reversed-Phase High-Performance Liquid chromatography (RP-HPLC) method for simultaneous determination of Cinitapride hydrogen tartrate and Pantoprazole sodium in its pharmaceutical dosage form. The method is simple, precise, economic, less time consuming and suitable for routine quality control analysis of both the drugs in formulation. The chromatographic separation was achieved on Thermoscientific BDS Hypersil C18 (250 × 4.6 mm, 5μl) column using a mixture of methanol and 0.1% v/v triethylamine (pH 6) in the ratio 85: 15 % v/v at a flow rate of 1.0 ml/min and UV detection at 264 nm. The retention times of Cinitapride and Pantoprazole were found to be 4.73 and 2.86 min respectively. The method shows linearity in the concentration range of 0.5-1.3 μg/ml for both the drugs with r2=0.9922 for Cinitapride and r2 =0.9974 for Pantoprazole. The LOD of Cinitapride and Pantoprazole were found to be 0.00164 μg/ml and 0.00042 μg/ml respectively. The LOQ of Cinitapride and Pantoprazole were found to be 0.00496 μg/ml and 0.00126 μg/ml respectively. The percentage recovery was found to be within the limits. The method for the determination of assay was below 2.0% RSD. Hence the developed HPLC method was applied for the estimation of Cinitapride and Pantoprazole in its pure form as well as in tablet dosage form and results was found to be in good agreement with the labeled claim. The developed method was found to be simple, accurate, precise, and specific and is useful in the quality control of bulk and pharmaceutical formulations.


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