Abstract

A simple, sensitive, precise, accurate, rapid and reproducible reverse phase high performance liquid chromatographic procedure is developed for simultaneous determination of rabeprazole sodium and itopride hydrochloride in solid dosage form. The mobile phase used was a combination of acetonitrile: buffer (35:65 v/v) and the pH was adjusted to 7.0 ± 0.1 by addition of triethylamine. The detection of the capsule dosage form was carried out at 266 nm and a flow rate employed was 1 mL/min. Linearity was obtained in the concentration range of 2 to 16 μg/mL of rabeprazole sodium and 5 to 55 μg/mL of itopride hydrochloride with a correlation coefficient of 0.9992 and 0.9996 respectively. The results of the analysis were validated statistically and recovery studies confirmed the accuracy of the proposed method.

Highlights

  • Rabeprazole sodium(RS) is chemically known as 2-({[4-(3-methoxy propoxy)-3-methyl-2pyridinyl]-methyl}sulfinyl)-1H-benzimidazole sodium salt (Figure 1)[1]

  • Literature survey revealed that various analytical methods such as estimation of rabeprazole sodium in tablet dosage form[3], simultaneous determination of rabeprazole and domperidone in pharmaceutical dosage form[4], development and validation of a dissolution test for rabeprazole sodium[5], liquid chromatographic/mass spectrometric assay of rabeprazole in dog plasma[6], quantitation of citalopram hydrobromide, donepezil hydrochloride and rabeprazole sodium[7] have been reported

  • RS and Itoride hydrochloride (IH) (10 mg each) were weighed accurately and transferred to separate 100 mL volumetric flasks. Both drugs were dissolved in 100 mL mobile phase to prepare standard stock solution of 100 μg/mL. for analysis of capsule dosage form (Label claim: 20 mg of rabeprazole sodium and 150 mg of itopride hydrochloride); twenty capsules were weighed, with and without shell, their average weight was determined and the content was finely powdered and powder equivalent to weight of one capsule was transferred to a 100 mL volumetric flask and dissolved in 50 mL mobile phase

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Summary

Introduction

Rabeprazole sodium(RS) is chemically known as 2-({[4-(3-methoxy propoxy)-3-methyl-2pyridinyl]-methyl}sulfinyl)-1H-benzimidazole sodium salt (Figure 1)[1]. There is no HPLC method reported yet for simultaneous estimation of rabeprazole sodium (RS) and itopride hydrochloride (IH) in combined dosage forms. It was thought to develop a simple, fast, accurate reproducible and economical method for the simultaneous estimation of rabeprazole sodium in combination with itopride hydrochloride in solid dosage form.

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