薬学および生命科学における研究開発の国際ジャーナル

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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UV SPECTROPHOTOMETRIC SIMULTANEOUS EQUATION METHOD FOR DETERMINATION OF EZETIMIBE AND GLIMEPIRIDE IN BULK DRUGS AND MARKETED FORMULATION

Hanifa Begum, Sh. Rizwan, Khaled Bin Sayeed, Asiya Fatima

Ezetimibe and Glimepiride used as Anti - hypercholesterolemia drugs. A simple , specific, accurate and precise stability indicating UV spectroscopy method has been developed and validated for simultaneous determination of Ezetimibe and Glimepiride in bulk drugs and marketed formulation (tablets). The developed method involves solving of simultaneous equations (Vierodt's method) using methanol as solvent where absorbance maxima λ max for GLIM and EZET was found to be at 226nm and 233nm respectively. Both the drugs obeyed Beer's law in the concentration range of 10- 30 μg/ ml & 1 – 3 μg/ ml. The method was validated as per ICH guidelines values of correlation coefficients (r2) 0.99 indicated good linearity of Calibration curve for both the drugs. The recovery of GLIM and EZET from the standard mixture solution was 99.65% and 100.3% respectively. The developed method was found to be accurate, reliable robust showing LOD 2.64 μg/ml (GLIM) and 26.4 μg/ml (EZET) and LOQ 8 μg/ml (GLIM) and 80 μg/ml(EZET) . Forced degradation was also performed the obtained spectra doesn’t show any degradation products under any stress conditions applied. Hence the method developed is stability indicating and can be used for estimation of EZET and GLIM in routine lab analysis.