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Improved Chromatographic Separation of Sitagliptin Phosphate and Metformin Hydrochloride

机译:改进的西格列汀磷酸酯和盐酸二甲双胍的色谱分离

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New UPLC method was developed for determination of sitagliptin and metformin using Symmetry C18 column (100 mm × 2.1 mm, 2.2 μm) and isocratic elution (methanol 20%), pH (3.5) as a mobile phase. The ultraviolet detector was operated at 220 nm and the column temperature was 50°C. Linearity parameters were acceptable over the concentration ranges of 2-12 μgml-1 and 5-35 μgml-1 for sitagliptin and metformin, respectively. The variables were premeditated to adjust the chromatographic conditions using design of experiment. The proposed method was proved to be accurate for the quality control of the mentioned drugs in their pharmaceutical dosage form.
机译:使用Symmetry C18色谱柱(100 mm×2.1 mm,2.2μm)和等度洗脱(甲醇20%),pH(3.5)作为流动相,开发了用于测定西他列汀和二甲双胍的新UPLC方法。紫外线检测器在220 nm下运行,柱温为50°C。西他列汀和二甲双胍的浓度范围分别为2-12μgml-1和5-35μgml-1,线性参数是可以接受的。使用实验设计对变量进行预调整以调整色谱条件。实践证明,所提出的方法对于所提及药物的药物剂型质量控制是准确的。

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