Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride,saxagliptin hydrochloride,and dapagliflozin in pharmaceutical tablets |
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Authors: | Hadir M. Maher Afnan E. Abdelrahman Nourah Z. Alzoman Haya I. Aljohar |
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Affiliation: | 1. College of Pharmacy, Department of Pharmaceutical Chemistry, King Saud University, Riyadh, Saudi Arabia;2. Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, University of Alexandria, Alexandria, Egypthadirrona@yahoo.com hshalaby@ksu.edu.sa |
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Abstract: | A capillary electrophoretic method coupled to a diode array detector (CE-DAD) was developed and validated for the simultaneous determination of metformin hydrochloride (MET), the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin hydrochloride (SAX), and the sodium glucose co-transporter (SGLT 2) inhibitor dapagliflozin (DAP). The proposed method was used for the determination of these drugs in binary antidiabetic combinations namely, SAX/MET, combination I, DAP/MET, combination II, and SAX/DAP, combination III. CE separation was performed on a fused silica capillary with background electrolyte consisting of 30?mM phosphate buffer (pH 6.0) with a high voltage of 30?kV, a pressure of 20 mbar, and an injection time of 40?s. The compounds were detected at 203?nm for SAX/DAP and 250?nm for MET. The method was linear in the concentration range of 10–200?µ?g/mL (SAX), 1.25–50?µ?g/mL (DAP), and 7.5–1000?µ?g/mL (MET). Full validation of the proposed method was performed as per the ICH guidelines. The obtained errors and deviation values did not exceed 2% assessing good accuracy and precision, respectively. The stability-indicating potential of the proposed method was proved under different stress-degradation conditions. The proposed method was successfully applied to the analysis of the three binary combinations in their tablets. |
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Keywords: | Capillary electrophoresis dapagliflozin metformin pharmaceuticals saxagliptin stability-indicating |
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