2016•Research Journal of Pharmacy and TechnologyOpen access

Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Esomeprazole and Domperidone in Tablet Formulation

Vitthal S. Hiwale, Sagar M. Bhangale, Sachin S. Rane, Milind E. Chaudhari, Rajesh Y. Chaudhari, Vijay R. Patil

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Abstract

A new simple, rapid, precise, and specific assay method was developed for simultaneous estimation of Esomeprazole and Domperidone in pure form and tablet form. The analysts were separated by RP HPLC on a RP-Purosnosphere C18 column (5 μm, 4.6mm, 250 mm). The mobile phase was methanol: water (72: 28 v/v) at 1.0 mL/min satisfactorily resolved the binary mixture. The UV detector was operated at 289 nm for the determination of both the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 20–120 μg/ml for Esomeprazole and Domperidone with a R2 0.9998 and 0.9990 values respectively, in binary mixture. The optimized method proved to be specific, robust and accurate for the quality control in bulk drug and pharmaceutical formulations.

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What this paper is about

A new simple, rapid, precise, and specific assay method was developed for simultaneous estimation of Esomeprazole and Domperidone in pure form and tablet form. The analysts were separated by RP HPLC on a RP-Purosnosphere C18 column (5 μm, 4.6mm, 250 mm). The mobile phase was methanol: water (72: 28 v/v) at 1.0 mL/min satisfactorily resolved the binary mixture. The UV detector was operated at 289 nm for the determination of both the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 20–120 μg/ml for Esomeprazole and Domperidone with a R2 0.9998 and 0.9990 values respectively, in binary mixture. The optimized method proved to be specific, robust and accurate for the quality control in bulk drug and pharmaceutical formulations.

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Available abstract

A new simple, rapid, precise, and specific assay method was developed for simultaneous estimation of Esomeprazole and Domperidone in pure form and tablet form. The analysts were separated by RP HPLC on a RP-Purosnosphere C18 column (5 μm, 4.6mm, 250 mm). The mobile phase was methanol: water (72: 28 v/v) at 1.0 mL/min satisfactorily resolved the binary mixture. The UV detector was operated at 289 nm for the determination of both the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 20–120 μg/ml for Esomeprazole and Domperidone with a R2 0.9998 and 0.9990 values respectively, in binary mixture. The optimized method proved to be specific, robust and accurate for the quality control in bulk drug and pharmaceutical formulations.

Key concepts: Domperidone, Esomeprazole, Mathematics, Chromatography, Biomedical engineering, Computer science, Medicine, Chemistry

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Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Esomeprazole and Domperidone in Tablet Formulation — Research Paper | ScholarLens