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A NEW STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF VOGLIBOSE IN BULK AND TABLET DOSAGE FORM USING AN ION PAIRING AGENT

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Samrat A. Khedkar, Swapnil R. Nazarkar, Amol A. Ban, Rajendra G. Kharade, Rachana S. Das
» doi: 10.17628/ecb.2019.8.376-383

Abstract

The analysis of voglibose by direct HPLC method is difficult due to its ability to show UV absorption at lower wavelength region. Here we have developed and validated a simple, sensitive, precise and specific reverse phase high performance liquid chromatography (RP-HPLC) method with ion pairing reagent, 1- hexane sulfonic acid for estimation of voglibose in bulk and its pharmaceutical dosage form (Tablets) The novelty of this method lies in the addition of the ion-paring salt directly. The proposed method was found to be more accurate, precise and easier compared to other reported methods where voglibose was needed to be derivatized to increase the sensitivity. The excipients in the tablet dosage forms did not interfere in the quantification of active drug by the proposed method. The HPLC separation was carried out by reverse phase chromatography on Cosmosil C18 (250mm x 4.6mm× 5µm) with a mobile phase composed of Methanol: Water (90:10) at pH 3 and flow rate was 1 mL/min. The detection was monitored at 221 nm. The calibration curve of voglibose was linear from 10 to 50µg/mL. The intraday and interday precision was found to be within the limit. The % recoveries for voglibose obtained in the accuracy study was 98.83-100.70%. LOD and LOQ for voglibose were found to be 0.4µg/mL and 1.22 µg/mL. Voglibose was also subjected to various stress condition like acid and alkali, hydrolysis, oxidation, photolysis and thermal degradation. The developed method is successfully applied for estimation of voglibose from bulk and tablet dosage form.

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