METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF EZETIMIBE AND GLIMEPIRIDE BY RP-HPLC
Journal Title: Int J of Pharm Res & Analy - Year 2016, Vol 6, Issue 1
Abstract
ABSTRACT A sensitive, selective and precise high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Ezetimibe and Glimepiride in tablet dosage form. The method employed like C18 column, Symmetry C18 (4.6 x 250mm, 5m, Make: Waters) as the stationary phase while Phosphate buffer (pH 3.6), Acetonitrile in proportion 45:55 v/v respectively. was used as mobile phase. The Retention time of Ezetimibe and Glimepiride were observed to be 2.273 and 3.630 minutes, respectively. The flow rate was found to be 1ml/min and effluents were monitored at 228 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for both Ezetimibe and Glimepiride and over a concentration range of 10-50 μg/ml. with correlation co-efficient of 0.9989 for Ezetimibe and and 0.9999 for Glimepiride. The LOQ was found to be 4.52 and 3.67μg/ml respectively for Ezetimibe and Glimepiride. The method was validated as per ICH guideline and it was found to be accurate, precise and robust. Marketed formulation was analyzed successfully. Keywords: Ezetimibe, Glimepiride, HPLC, Validation etc.
Authors and Affiliations
Sudheer Kumar N*, Shilpa K, Ajitha A , Uma Maheswara Rao V
Keywords
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