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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE & GLIMEPIRIDE IN FIXED DOSE COMBINATION AND EVALUATION OF 5 MARKETED FORMULATIONS BY QUALITY BY DESIGN

Rayudu.Lakshmiprasanna*, Dr.M.Prasada Rao, Mannempalli.Chandana, Doredla. Narasimha rao, Kasu.Naga Harini

Department of Pharmaceutical Analysis, M.A.M College of Pharmacy, Kesanupalli, Narasaraopet 522601

ABSTRACT

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Metformin hydrochloride&glimepride in pure and in fixed dose combinations. A Symmetry C18 (4.6 x 150mm, 5m, Make: XTerra) or equivalent was used with a mobile phase containing a mixture of pH 3.0 Potassium dihydrogen Phosphate: ACN (40:60). The flow rate was 1.0ml/min and effluent was monitored at 230nm and eluted at 8min. Calibration curve was plotted with a range from 5-25 μg/ml for Metformin Hydrochloride & Glimepiride is 10-50 μg/ml. The assay was validated for the parameters like precision, accuracy, robustness and ruggedness parameters. The prsoposed method can be useful in the routine analysis for the determination of metformin hydrochloride&glimepride in combined tablet dosage form. For QbD select 5 Different Brands , For These Conduct Dissolution Studies In Different Buffers Like water, 4.0 PH Acetate Buffer,6.8 PH Buffer, 7.2 PH Phosphate Buffer, In Different Buffer Volumes Like 500ml,1000ml,In Different Dissolution Apparatus like Paddle& Basket,In Different rpms like 25,50,75,100 & in Different Alcoholic Concentrations Like 0%, 5%,10%,20%,40%.these Results are compared with the innovator product this will gives the information about the invitro & invivo correlation of the drugs.

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