Stability-indicating capillary electrophoresis method for the simultaneous determination of metformin hydrochloride, saxagliptin hydrochloride, and dapagliflozin in pharmaceutical tablets

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.

Graphical Abstract

Keywords:

• Capillary electrophoresis
• dapagliflozin
• metformin
• pharmaceuticals
• saxagliptin
• stability-indicating

Additional information

Funding

The authors would like to extend their appreciation to the Deanship of Scientific Research at King Saud University for its funding of this research through the research group project number RGPVPP-331.