Glimepiride is antidiabetic drug and Ezetimibe is cholesterol absorption inhibitor.The combination of this two drug is used for the treatment of hypercholesterolemia.Two new, simple, accurate and precise uv spectrophotometric methods have been developed amd validated for the simultaneous determination of Glimepiride (GLM) and Ezetimibe (EZE) in their combine dosage forms. The first method is based on the simultaneous equations for analysis of both the drugs using methanol as solvent. Glimepiride has absorbance maxima at 228 nm and Ezetimibe has absorbance maxima at 247 nm in methanol. The second method is first order derivative method and wavelengths selected for quantitation were 234 nm for Glimepiride( zero crossing point for Ezetimibe) and 228 nm for Ezetimibe(zero crossing point for Glimepiride).The linearity was obtained in the concentration range of 6-16 μg/ml for both the drug. Both methods were validated statistically and recovery studies carry out.The method was successfully applied to tablet Dosage Form because no interference from the mixture excipients was found. The suitability of this method for the quantitative determination of Glimepiride and Ezetimibe was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of Glimepiride and Ezetimibe in combination. The results of analysis have been validated statistically and by recovery studies.The validation study is statistically significant as all statistical parameter are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision.
Loading....