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Asian Journal of Pharmaceutical Research
Year : 2019, Volume : 9, Issue : 4
First page : ( 238) Last page : ( 242)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2019.00038.8

Development and Validation of Spectroscopic Simultaneous Equation Method for Simultaneous Estimation of Itopride Hydrochloride and Omeprazole in Synthetic Mixture

Varachhiya Hiral J., Barse Rohan K., Jain Suresh*

Department of Pharmaceutical Quality Assurance, Shree Dhanvantary Pharmay College, Kim (Surat)-394110, India

*Corresponding Author E-mail: jdsuresh@gmail.com

Online published on 31 December, 2019.

Abstract

A Simple, rapid, accurate, precise spectrophotometric method was developed and validated for simultaneous estimation of Itopride Hydrochloride and Omeprazole in synthetic mixture. The method is based on the simultaneous equation method. Itopride Hydrochloride has absorbance maxima at 258 nm and Omeprazole has absorbance maxima at 300 nm in methanol. Both drugs obey Beer's law in the concentration range of 10–50 μg/ml (R2= 0.9994) for Itopride Hydrochloride and 2.5–12.5μg/ml (R2=0.9992) for Omeprazole. Limit of detection is 0.105 and 0.052 μg/ml and Limit of quantification is 0.320 and 0.160 μg/ml for Itopride Hydrochloride and Omeprazole, respectively. Percentage recovery for assay was found to be 99.68% and 100.06% for Itopride Hydrochloride and Omeprazole, respectively. The accuracy and reproducibility of the praposed method was statistically validated by recovery studies. The method was validated according to the ICH guidelines.

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Keywords

Itopride Hydrochloride, Omeprazole, Simultaneous Equation Method, Validation.

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