Analytical method for simultaneous estimation of voglibose and mitiglinide calcium hydrate by validated RP-HPLC method

Abstract

A combination of Voglibose and Mitiglinide calcium hydrate is used in Type- 2 diabetes. The method was based on pre-column derivatization of Voglibose with 9-Fluorenylmethyloxycarbonyl chloride due to lack of chromophoric group it cannot directly estimated by UV detector in Reverse Phase High Performance Chromatography (RP-HPLC) method. The chromatographic separation was achieved using phosphate buffer (pH 4.0) and methanol (30:70) as mobile phase. Detection was carried out at 233 nm using UV detector. The retention time of Voglibose and Mitiglinide calcium hydrate were found to be 5.233 min and 3.580 min respectively. The RP-HPLC method for Voglibose and Mitiglinide calcium hydrate was found to be linear over the range of 0.5-1.50 µg/mL and 25-75 µg/mL respectively. Correlation coefficient for Voglibose and Mitiglinide calcium hydrate was found to be 0.998 and 0.999 respectively. Accuracy for Voglibose and Mitiglinide calcium hydrate was 99.79-100.94 % and 100.69-100.88 % respectively. A simple, specific, accurate and precise RP-HPLC method based on pre-column derivatization has been developed. There is a significant advantage in using 9- Fluorenylmethyloxycarbonyl chloride reagent, as the whole derivatization procedure is completed in a few minutes and easy to handle. All validation parameters lie within its acceptance criteria as per International Council for Harmonisation (ICH) guideline. The proposed RP-HPLC method can be highly suitable for analysis of Voglibose and Mitiglinide calcium hydrate without interference.