Determination of the Antidiabetic Drug Miglitol in Pharmaceuticals by Ultra-Performance Liquid Chromatography

Abstract

Miglitol (MGL) is a drug used in the treatment of type-2 diabetes mellitus. A new analytical method employing ultra-performance liquid chromatography (UPLC) with UV-detection is presented for the determination of MGL in bulk drug and tablet forms. Analysis was performed in less than 3 min in isocratic mode on a reversed phase BEH C₁₈ (100 mm × 2.1 mm; 1.7 µm particle size) column using phosphate buffer of pH 3.7-acetonitrile (35:65 v/v) as mobile phase, pumped at a flow rate of 0.3 ml min^-1 and with UV detection at 270 nm. The column temperature was maintained at 30 °C and the volume injected was 2µl. Chromatographic conditions for a rapid elution of the analyte with a symmetric peak and highest number of theoretical plats were thoroughly studied and optimized. The calibration graph was linear over the concentration range 0.1–150 µg ml^-1 with limits of detection (LOD) and quantification (LOQ) values of 0.003 and 0.01 µg ml^-1, respectively. Precision expressed as %RSD ranged from 0.22% to 0.59%, and accuracy was better than 1.5% (RE). Analysis was performed under slightly altered optimum conditions as part of robustness study, and results were not significantly different from those obtained under optimum conditions. Equipment-to-equipment and analyst-to-analyst deviations were also not significant, testifying the method ruggedness. The developed method was validated for selectivity by placebo blank and synthetic mixture analyses. The method, when applied to tablets, yielded results which were in agreement with the label claim and also with those of reference method. To determine the stability-indicating ability of the method, MGL was subjected to forced degradation by exposing it to acid and base hydrolysis, oxidation, heat and light. The results revealed that the drug is amenable to slight degradation under acid- and oxidant-induced stress conditions, but remained intact under other conditions.

Keywords: Miglitol (MGL), determination, ultra-performance liquid chromatography (UPLC), pharmaceuticals, stability-indicating

Cite this Article

Basavaiah K, Rajendraprasad N. Determination of the Antidiabetic Drug Miglitol in Pharmaceuticals by Ultra-Performance Liquid Chromatography. Research and Reviews: A Journal of Pharmaceutical Science. 2018; 9(2):
11–26p.