Development of HPLC-MS Method of Voglibose and Quercetin Quantitation in Hypoglicemic Action Tablets

Abstract

Aim. The purpose of our study was to develop a method for simultaneous quantitation of voglibose and quercetin in a solid dosage form. Materials and methods. The objects of the study were voglibose, quercetin, tablets containing voglibose - 0.2 mg and quercetin 100 mg. Measurements were carried out by high-performance liquid chromatography (HPLC) according to SPHU, supp. 1, 2.2.29, N, using the following equipment: a mass-selective detector Agilent 6530 Q-TOF was used as the detecting system. Results. According to the developed method, the quantitative determination of voglibose and quercetin in the tablets of hypoglycaemic action was investigated. The following results were obtained: the content of C 10 H 21 NO 7 (voglibose) in one dosage unit of the test drug was 0.2 mg; and the content of C 15 H 10 O 7 (quercetin) -0.105 g, which suggests the validability of the proposed method for quantitation of the active substances in tablets for the prevention and treatment of type II diabetes mellitus. Conclusions. In the course of the study, a method was developed for determination of voglibose and quercetin in a hypoglycaemic action preparation using high-performance liquid chromatography (HPLC) with a gradient mode of elution. It has been established that the chosen chromatographic conditions allow quantitative determination of the active pharmaceutical ingredients studied in a solid dosage form with a tolerance of ±5 %. Validation of the developed methodology has been conducted and its suitability for the simultaneous quantification of quercetin and voglibose in tablets has been demonstrated. The reproducibility of this method has been proved.