Validated Rp- Hplc Method for Simultaneous Estimation of Metformin Hydrochloride and Benfotiamine in Bulk Drug and in Pharmaceutical Dosage Form

A new simple, precise, accurate, selective and economical RP-HPLC method has been developed and validated for simultaneous estimation of Metformin Hydrochloride (MET) and Benfotiamine (BEN) in tablet dosage form. The method was carried out on a Waters column C-18 (250 mm x 4.6 mm, 5 μm) with a mobile phase consisting of water (pH 3.2 adjusted with ortho-phosphoric acid) and acetonitrile (75:25 v/v); at a flow rate of 0.8 mL min with run time of 10 min. Detection was carried out at 254 nm. The retention time for MET and BEN was found to be 2.125 and 3.881 min, respectively. The MET and BEN followed linearity in the concentration range of 200600 μg mL and 3090 μg mL with r= 0.999, respectively. The amounts of both drugs estimated by proposed method were found to be in good agreement with label claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The LOD and LOQ were found to be 0.49 and 0.19 μg for MET and 1.6 and 0.65 μg for BEN respectively. The developed method can be used for routine analysis of titled drugs in tablet formulation. © 2011 Universal Research Publications. All rights reserved