Development and validation of RP-HPLC method for Empagliflozin and Metformin HCL
A simple, specific and accurate RP-HPLC method was developed and validated for simultaneous determination of Empagliflozin and Metformin hydrochloride in bulk and Pharmaceutical dosage form. Chromatographic separation was carried out on Grace C18 column (250×4.6mm, 5µm), Methanol: Water pH 3.0 in the ratio of 80:20 % v/v, Flow rate is 0.8 ml/min and UV detection at 227nm.The Retention times of Empagliflozin and Metformin hydrochloride were found to be 2.630 min and 5.133min, respectively. The validation parameter studied were linearity, accuracy, precision, specificity and robustness i.e. pH of the mobile phase on the retention behavior. The proposed method was validated as per ICH guideline
Keywords:Empagliflozin, Metformin HCL, RP-HPLC, Effect of pH, Analytical method validation
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Copyright (c) 2017 Sushil D. Patil, Sunil V. Amurutkar, Chandrashekhar D. Upasani
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