Method for determining content of impurities in linagliptin raw material
A technology of impurity content and API, applied in the field of biomedicine, can solve the problems affecting the quality of linagliptin products and the efficacy of linagliptin, and achieve the effects of quality control, good separation, and real measurement.
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[0056] Example 1
[0057] In this example, the inventor introduced in detail the development process of the method for determining the content of impurities in the linagliptin bulk drug.
[0058] 1.1 Determination of buffer salt type and pH value
[0059] Linagliptin contains a primary amine group. CAD software predicts that the pKa of its conjugate acid is as high as 10.0, which is relatively strong. Linagliptin also contains a number of basic groups, all of which are connected to more complex groups. The acidity and alkalinity are difficult to judge. It is necessary to select a buffer with a suitable pH value to ensure that the compound to be separated exists in a single form during the separation process, so as to achieve a single peak, a sharp peak shape, and a separation effect that reproduces the retention time. Therefore, at the initial stage of method development, the inventors investigated the separation effect of linagliptin and corresponding impurities under the same gra...
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[0085] Example 2
[0086] In this example, the inventor investigated the system applicability and sensitivity of the method for determining the impurity content in the linagliptin bulk drug determined in Example 1, and introduced in detail how to base on the chromatographic conditions determined in Example 1. Under the chromatogram obtained, calculate the content of impurities.
[0087] 2.1 Preparation of related solutions
[0088] The diluent (blank solution) is: a mixed solution of acetonitrile: phase A=1:4;
[0089] Test solution: Take about 20 mg of the test substance, accurately weigh it, and place it in a 100mL volumetric flask. Use an appropriate amount of diluent to dissolve, sonicate and dilute to the mark. Shake well to obtain, and prepare 2 copies in parallel;
[0090] System suitability solution: Take about 4mg of impurity A reference substance, weigh it into a 100mL volumetric flask, accurately pipette 5mL of test solution 1 to the same 100mL volumetric flask, add diluent ...
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