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Scholars Academic Journal of Pharmacy | Volume-7 | Issue-07
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
M. Tandrima, S. Lakshmi, Dr. A. Yasodha
Published: July 30, 2018 |
271
182
DOI: 10.21276/sajp.2018.7.7.7
Pages: 341-347
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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.