Archive \ Volume.4 2013 Issue 5

STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF VOGLIBOSE IN BULK AND TABLET DOSAGE FORM

Shubhangi C. Daswadkar , Sanjay G. Walode and Mahendra Kumar CB
Abstract

A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of voglibose both in bulk drug and tablet dosage form. The drug was separated using a mobile phase acetonitrile: water, (20:80 v/v) on an Agilent, TC C18 (250 × 4.6 mm) 5μm column at flow rate of 1.0 ml/min at ambient temperature and detection was performed at 272 nm. The retention time was 3.17 ± 0.01 min for voglibose. The detector linearity was established in concentrations ranging from 10-70μg/ml, the regression coefficient was 0.9992. For stability study, the drug was exposed to the stress conditions such as acid, base, oxidation, neutral and sunlight as per the recommendations of ICH guidelines. The results of the analysis were validated in terms of specificity, limit of detection, limit of quantification, linearity, precision and accuracy As per ICH guidelines and were found to be satisfactory. The high recovery and low relative standard deviation confirm the suitability of these methods can be employed for the routine analysis of tablet containing voglibose.