RP-HPLC method development and validation for estimation of Voglibose in bulk and tablet dosage forms

Abstract

A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of voglibose in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on RP-18e, Hibar RT column (250×4.6mm) with a mobile phase composed of 0.025M potassium dihydrogen phosphate pH 2.5 : acetonitrile: methanol (40:55:5) in isocratic mode at a flow rate of 1ml/min. As voglibose cannot be directly detected with high sensitivity, it was derivatized with Taurine and sodium periodate. The detection was monitored at 282nm. The calibration curve for voglibose was linear from 100 to 500ng/ml. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of voglibose in bulk and its tablet dosage forms. LOD and LOQ for voglibose were found to be 30ng/ml and 100ng/ml. Accuracy (recoveries: 99.8-101.2%) and reproducibility were found to satisfactory.