STABILITY INDICATING METHOD EVALUATION AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF GLIMEPIRIDE, METFORMIN AND VOGLIBOSE IN ORAL DOSAGE FORM USING LCMS
Mohd. Kareem Ahmed*, Dr. Osman Ahmed* and Dr. Anas Rasheed
ABSTRACT
A specific, precise, accurate ultra pressure liquid chromatography (UPLC) method is developed for estimation of Glimepiride + Metformin + Voglibose in bulk drug and market dosage form. The method employed, with Hypersil C18 (100 mm x 2.1 mm, 1.7 μm) in a gradient mode, with mobile phase of Acetonitrile and Methanol in the ratio of 68:32%v/v. The flow rate was 1.0 ml/min and effluent was monitored at 260 nm. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 20- 100 μg/ml respectively. The LOD and LOQ values for were found to be 0.2099 (μg/ml) and 0.6362 (μg/ml) respectively. No chromatographic interference from excipients and degradants were found. The proposed method was successfully used for estimation of Glimepiride + Metformin + Voglibose in market dosage form.
Keywords: Metformin, Glimepiride, Voglibose, oral dosage form, UPLC Stability indicating method.
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