TLC DETERMINATION OF GLIMEPIRIDE AND ITS MAIN IMPURITIES IN PHARMACEUTICALS

Abstract

A quantitative TLC method was developed for the simultaneous separation and quantification of glimepiride and its main degradation impurities, glimepiride-sulfonamide, and glimepiride-carbamate. Chromatographic analysis was performed using the commercial aluminum-backed TLC plates precoated with silica gel 60F₂₅₄ as stationary phase and toluene-ethyl acetate–methanol 8:5:1 (v/v) as the mobile phase. Detection was performed at 230 nm. Regression coefficients (r > 0.997), recovery (94.9 to 105.1%), determination limit of impurities (7 ng spot⁻¹ equivalent to the 0.1% impurity level), and robustness were validated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of glimepiride in its dosage forms.

Keywords:

• glimepiride
• hypoglycemic drug
• impurities
• pharmaceutical dosage forms
• quantification
• TLC

ACKNOWLEDGMENT

This work was supported by the Ministry of Science and Technological Development of the Republic of Serbia, Contract No. 172033.