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 60F(254) as stationary phase and toluene-ethyl acetate-methanol 8:5:1 (v/v) as the mobile phase. Detection was performed at 230nm. Regression coefficients (r>0.997), recovery (94.9 to 105.1%), determination limit of impurities (7ng 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.