Title: |
Applications of ION Pair HPLC in Determination of Metformin Hydrochloride and Linagliptin in Tablet
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Authors: |
Chung Duong Dinh, Trang Nguyen Thi Thu, Quan Nguyen Huu Khanh, Yen Nguyen Thi Ngoc |
Source: |
International Journal of Latest Engineering Research and Applications, pp 01 - 07, Vol 08 - No. 09, 2023 |
Abstract: |
Introduction: The combination form of metformin and linagliptin improves glucose metabolism in treating type 2 diabetes. Objective: Establishing an analytical process to determine metformin and linagliptin in tablets by reverse-phase high-performance liquid chromatography (Rp-HPLC). Methods: Various parameters, including detection wavelength, mobile phase, stationary phase, SDS and ion concentration, pH value, flow rates, sample injection volumes, and column temperatures, were systematically investigated to optimize the chromatographic procedure. Results: Optimized chromatographic conditions for determining metformin and linagliptin are followed: Zorbar eclipse plus C18 column (100 x 4.6 mm, 3.5 μm), PDA detector (detection wavelength of 226 nm). The mobile phase was a mixture of methanol, acetonitrile, and phosphate buffer solution containing 1.75 mM SDS at pH 6.8 (7:33:60, v/v/v); Flow rate was 1 mL/min; Sample injection volume was 10 μl; and the column oven temperature was set at 40oC. The linear ranges of metformin and linagliptin are 7.66 - 45.97 μg/mL and 1.25 - 7.52 μg/mL, respectively (R2> 0.999). A metformin and linagliptin quantification method has been successfully established and validated by the Rp-HPLC method. Conclusion: The procedure was developed and validated according to ICH guidelines and applied to determine metformin and linagliptin in combination tablets. |
Keywords: |
Metformin hydrochloride, Linagliptin, Rp-HPLC, Validation |
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DOI: |
10.56581/IJLERA.8.9.01-07 |
