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.
Highlights
Today, diabetes mellitus (DM) is one of the leading medical and social problems that is rapidly gaining momentum: more than 300 million people worldwide suffer this disease [1]
As active pharmaceutical ingredients (APIs), according to the pharmacological studies, it is suggested to use a combination of voglibose and quercetin [6]
Measurements were carried out by high-performance liquid chromatography (HPLC) according to SPHU, supp .1, 2.2.29, N [16], using the following equipment: a mass-selective detector Agilent 6530 Q-TOF was used as the detecting system
Summary
Diabetes mellitus (DM) is one of the leading medical and social problems that is rapidly gaining momentum: more than 300 million people worldwide suffer this disease [1]. According to the forecasts of the World Health Organization, by 2035 the number of patients with diabetes will increase to 592 million [2]. In Ukraine, according to statistics, the number of patients with diabetes at the beginning of 2018 was 104 thousand, but the real indicator of this pathology incidence is almost 2 times higher [3]. It is proved that monotherapy of type II DM with only one of oral hypoglycaemic drugs has positive results only in the first 5–6 years of the disease, in the future there is a need for the (2019), «EUREKA: Health Sciences» Number 3 combination therapy with drugs from different groups [4]. As active pharmaceutical ingredients (APIs), according to the pharmacological studies, it is suggested to use a combination of voglibose and quercetin [6]
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