Abstract

Worldwide, 25% of the population suffers from metabolic syndrome (MetS). The treatment of patients with MetS regularly includes drugs prescribed simultaneously to treat several disorders that manifest at the same time, such as hypercholesterolemia, arterial hypertension, and diabetes. To the authors’ best knowledge, there is no previous published analytical method for the simultaneous quantification of drugs used in the treatment of these diseases. In the present study, a rapid high-performance liquid chromatography with a diode-array detector HPLC-DAD methodology was developed for simultaneous quantification of carvedilol (CVD), telmisartan (TEL), bezafibrate (BZT), gliclazide (GZD), and glimepiride (GMP) in bulk and pharmaceutical form. The chromatographic separation of the five pharmaceuticals was achieved on a Hypersil GOLD C18 Selectivity (5 µm, 150 × 4.60 mm2) using a mobile phase of acetonitrile (50%) and 0.02 M KH2PO4, pH 3 (50%) at a flow rate of 1 mL/min and at 25 °C. The total separation time was 9 min. The analytical method was validated following the International Conference on Harmonization guidelines. A reproducible method was obtained with acceptable limits of detection (LOD) and quantification (LOQ) for CVD (0.012 and 0.035 μg mL−1), TEL (0.103 and 0.313 μg mL−1), BZT (0.025 and 0.076 μg mL−1), GZD (0.039 and 0.117 μg mL−1), and GMP (0.064 and 0.127 μg mL−1). The validated method allowed the determination of these drugs in commercial pharmaceutical products both individually and simultaneously. The present method was found to be suitable for simultaneous quantification of the five drugs that are most commonly used in the simultaneous treatment of the metabolic syndrome.

Highlights

  • Worldwide, at least one in every four people suffer from metabolic syndrome (MetS) [1].Obesity is a crucial factor in getting MetS, and this condition is reaching epidemic proportions

  • 0.076), gliclazide (0.039 and 0.117), and glimepiride (0.064 and 0.127), in units of μg mL−1, respectively. These results show that this methodology allows quantification of the active pharmaceutical ingredient (API) in concentrations under 0.313 μg mL−1, and detection in the range of 0.012–0.103 μg mL−1

  • LOQ for each API %RE was lower than 15%, which validates the methodology’s limit of quantification

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Summary

Introduction

At least one in every four people suffer from metabolic syndrome (MetS) [1]. Obesity is a crucial factor in getting MetS, and this condition is reaching epidemic proportions. In the U.S, 68% of the population is considered overweight or obese [2]. MetS is defined as a constellation of interrelated risk factors that appear to promote diabetes and cardiovascular diseases [3]. A patient with MetS will suffer from hypertension, hypercholesterolemia, and diabetes simultaneously [4].

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