A Stability-Indicating RP-HPLC Approach for Assessing Glimepiride Content in Formulations

Abstract

This investigation reports the advancement of a robust and reliable RPHPLC technique for the accurate quantification of glimepiride in dose form with particular emphasis on stability assessment. The technique was designed to achieve effective chromatographic separation of glimepiride from its degradants, which are commonly formed during storage. Efficient separation was attained using a C18 column with dimensions of 25 cm ,4.6 mm, 5 μm) and a movable phase comprising of acetonitrile and monobasic sodium dihydrogen phosphate of strength 20 mM buffer at pH 5 in a 60:40 ratio, pumped at a 1.0 mL/min. Identification was done at 228 nm, yielding a elution time for glimepiride of 7.214 minutes. Forced degradation studies demonstrated that glimepiride was susceptible to neutral, acidic, alkaline, hydrolytic, thermal and oxidative condition, whereas it remained stable under photolytic conditions. Method validation, conducted in accordance with regulatory guidelines, confirmed the validity of the method for routine quantification. Furthermore, the forced degradation results verified the method’s degradation monitoring capability, allowing reliable estimation of glimepiride content even in the influence of degradants. In conclusion, the developed RP-HPLC technique provides a reliable analytical tool for quality assessment and stability monitoring of glimepiride drug product, thereby supporting the assurance of product quality and therapeutic integrity.