Development and Validation of a RP-HPLC-PDA Method for the Simultaneous Determination of Metformin and Benfotiamine in Active Pharmaceutical Ingredient and Pharmaceutical Dosage Form
Journal Title: Scholars Academic Journal of Pharmacy - Year 2018, Vol 7, Issue 7
Abstract
Abstract: A new simple, sensitive, accurate and economical analytical method was developed for the simultaneous estimation of Benfotiamine and Metformin in pure and tablet dosage form by RP-HPLC. The method was performed with. Phenomenex Gemini C18 (4.6×250mm) 5μ with mobile phase containing TEA buffer (pH 4.0): Methanol in proportion 65:35 v/v respectively; at a flow rate of 1ml/min with a run time of 6 minutes; detection was done at 230 nm. The retention time of MET and BEN is found to be 3.643 and 2.121 respectively for the standard and for the sample the retention time was found to be 3.649and 2.142 respectively. The MET and BEN followed linearity in the concentration range of 20-100 µg/ml and 10-50 µg/ml with r2 = 0.99 respectively. The amount of the drugs estimated by proposed method was found to be in agreement with the label claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The method precision for the determination of assay was below 2% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Authors and Affiliations
M. Tandrima, S. Lakshmi, Dr. A. Yasodha
Keywords
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