Abstract

A simple, novel, accurate, precise, linear, rapid and economical RP-HPLC method was developed for the estimation of Benfotiamine. The chromatographic separation was achieved using a Grace Smart RP 18 (250 x 4.6 mm, 5 μ) column and isocratic elution, a mobile phase comprising of Acetonitrile: 50mM Ammonium acetate buffer at PH 6.0 was adjusted with O-Phosphoric acid in the ratio of 60:40 (v/v). The flow rate was 1.0 ml/min with detection at 245 nm using a UV detector and drug eluted with retention time of 2.743 min. The calibration curves were linear (r²=1) in the concentration range of 2-64 μg/ml. The limit of detection and limit of quantitation were found to be 0.1727 and 0.5235 μg/ml respectively. Thus the simple, novel, economical, accurate, precise and rapid RP-HPLC method was developed for estimation of Benfotiamine and validated as per ICH guidelines. Hence the method holds good for routine analysis of Benfotiamine in pure and pharmaceutical dosage form.

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