#158 A stability indicating RP-UPLC method for the simultaneous estimation of Metformin, Dapagliflozin and Saxagliptin in bulk and tablet dosage form

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Velmurugan, D. .; Dhanabalan , K. .; D, K. .; Vairavel, S. .; Ramanathan , S. . #158 A Stability Indicating RP-UPLC Method for the Simultaneous Estimation of Metformin, Dapagliflozin and Saxagliptin in Bulk and Tablet Dosage Form. J Pharm Chem 2022, 8.

Abstract

To develop a simple, accurate, precise, and rapid analytical method validation for stability-indicating RP-UPLC method for the simultaneous estimation of Metformin, Dapagliflozin, and Saxagliptin in bulk and tablet dosage form. The separation was carried out on CHS C18 (100 x 2.1 mm) 1.7 µm column, with the mobile phase composition of Water: Methanol (50:50 v/v). Flow rate: 0.3 mL/min. UV detection was carried out at 222 nm. The developed method was validated for linearity, accuracy, precision, the limit of detection, and quantification as per ICH guidelines. The linearity of the drugs from the concentration range of 5-30 µg/mL was established by constructing the calibration curve with a concentration on the X-axis and peak area on the Y-axis with the correlation coefficient of 0.999. The retention time of Metformin, Dapagliflozin, and Saxagliptin was found to be 1.060 min, 1.502 min, and 2.176 min. The %RSD of system precision for Metformin, Dapagliflozin, and Saxagliptin was found to be 1.0, 0.7, and 0.7, respectively. The %RSD of method precision for Metformin, Dapagliflozin, and Saxagliptin was found to be 0.7, 0.7, and 0.8, respectively. Percentage recovery was obtained as 99.63%, 100.26%, and 99.78% for Metformin, Dapagliflozin, and Saxagliptin, respectively. A new simple analytical method has been developed for the Simultaneous Estimation Of Metformin, Dapagliflozin and Saxagliptin in Bulk and Tablet Dosage Form.

References

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