Abstract
VALIDATED UHPLC-PDA METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN, GLIMEPIRIDE AND PIOGLITAZONE IN THEIR FDC TABLETS

Hamid Khan*

ABSTRACT

In the presented work the Ultra-High Performance Liquid Chromatographic-Photodiode Array Detection (UHPLC-PDA) method has been developed and validated for simultaneous determination of Anti-diadetic drugs such as Metformin, Glimepiride and Pioglitazone in their Fixed Dose Combination (FDC) tablets. The chromatographic separation was achieved on Acquity UPLCTM BEH C18 (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.25 mL/min. The detection was carried out at 250 nm by PDA detector. The elution of metformin, glimepiride and pioglitazone was occurred at 0.75 min, 1.50 min and 2.25 min, respectively. The calibration curves were linear over the concentration range of 1-1000 ng/mL for all the drugs. The developed method was validated according to ICH guidelines. The proposed method was applied for simultaneous determination of metformin, glimepiride and pioglitazone during routine quality control analysis in their combined tablets.

Keywords: UHPLC-PDA, Anti-diabetic drugs, FDC, Validation, Determination.


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