Abstract

VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND GLIMEPIRIDE IN BULK AND COMBINED DOSAGE FORM

Ganesh Manohar Guthi*, Shanta Kumari Katakam, Surendra Nama,Sambasiva rao Pathakamuri

Abstract

A new Simple, Precise, Fast and Accurate RP-HPLC Method has been developed and validated for simultaneous estimation of Metformin Hydrochloride (MET) and Glimepiride (GLM) in bulk and combined dosage form. The method was carried out on a Agilent CN (250mm × 4.6mm i.d, 5μm) column with mobile phase consisting of Buffer and Acetonitrile in the ratio of 45:55v/v and flow rate of 1ml/min. The detection was carried out at 229 nm. The retention time of MET and GLM were found to be 2.868min and 5.104min respectively. The MET and GLM followed linearity in the concentration range of 0.2-3.03 μg/ml and 10.01-150.15 μg/ml respectively with r²=0.999 for both MET and GLM .The amount of both drugs estimated by the proposed method was found to be in good agreement with labelled claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in combined dosage form.

Keywords: Metformin HCL, Glimepiride; RP-HPLC, Validation, CN column.