Synchronized Determination of Four Antidiabetic and Antihyperlipidemic Drugs by a Validated LC Method

Abstract

A rapid, simple, and precise RP-LC method was developed for simultaneous determination of alogliptin (ALO), pioglitazone (PIO), glimepiride (GLM), and ezetimibe (EZB) in laboratory prepared mixtures and pharmaceutical formulations. Chromatographic separation was achieved using isocratic elution mode using a mobile phase of acetonitrile: 0.02 M potassium dihydrogen phosphate (pH: 3.4) (54:46; v/v) flowing through a C18 Thermo^® column (BDS Hypersil, 25 cm × 4.6 mm − 5 µm) at a rate of 1 mL min⁻¹ at ambient temperature. UV detection was carried out at 230 nm. The method was validated according to ‘International Conference on Harmonization’ guidelines. Linearity, accuracy, and precision were satisfactory over concentration ranges (µg mL⁻¹): 0.0625–125 for ALO, 0.075–150 for PIO, 0.1–200 for EZB, and 0.01–20 for GLM. Coefficients of determination were >0.99 for all analytes. Limits of quantification (LOQs) were found to be: 0.032 µg mL⁻¹ for ALO, 0.041 µg mL⁻¹ for PIO, 0.011 µg mL⁻¹ for EZB, and 0.007 µg mL⁻¹ for GLM. The developed method is specific, accurate, and suitable for quality control and routine analysis of the cited drugs in their pharmaceutical products.

Graphical Abstract