A method for analyzing related substances in azilsartan raw material and its preparation
A technology of related substances and analysis methods, applied in the field of analysis of related substances in azilsartan raw materials and preparations thereof, can solve problems such as inability to apply azilsartan detection, and achieve increased accuracy, accurate quantitative analysis, and specificity. Good results
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Embodiment 1
[0049] High performance liquid chromatography conditions:
[0050] Octadecylsilane bonded silica gel column (250×4.6mm, 5μm), with pH=2.2 phosphoric acid aqueous solution as mobile phase A, and a mixed solution of pH=2.2 phosphoric acid aqueous solution and acetonitrile with a volume ratio of 12:88 as mobile phase For phase B, gradient elution is performed, the flow rate is 1.0ml / min, the detection wavelength is 250nm, and the column temperature is 35°C;
[0051] The gradient elution process is: within 0-5min, the volume ratio of mobile phase A and mobile phase B is 70:30; within 5-25min, the volume ratio of mobile phase A and mobile phase B is gradually changed from 70:30 to 50:50; within 25-50min, the volume ratio of mobile phase A and mobile phase B is gradually changed from 50:50 to 40:60; within 50-60min, the volume ratio of mobile phase A and mobile phase B is uniformly changed from 40:60 Gradually change to 30:70; within 60.01-70min, the volume ratio of mobile phase A ...
Embodiment 2
[0057] Octadecylsilane bonded silica gel column (250×4.6mm, 5μm), with pH=2 phosphoric acid aqueous solution as mobile phase A, and a mixed solution of pH=2 phosphoric acid aqueous solution and acetonitrile with a volume ratio of 14:86 as mobile phase For phase B, gradient elution was performed at a flow rate of 1.05 ml / min, a detection wavelength of 248 nm, and a column temperature of 30° C.; the gradient elution process was the same as in Example 1.
[0058] Sample preparation:
[0059] Test solution: Take about 50 mg of azilsartan test product, weigh it accurately, put it in a 50ml measuring bottle, add an appropriate amount of methanol to dissolve and dilute to the mark, shake well, and use it as the sample solution.
[0060] Test operation: Take 10 μl of the test solution and inject it, and record the chromatogram.
Embodiment 3
[0062] Octadecylsilane bonded silica gel column (250×4.6mm, 5μm), with pH=2.4 phosphoric acid aqueous solution as mobile phase A, and a mixed solution of pH=2.4 phosphoric acid aqueous solution and acetonitrile with a volume ratio of 10:90 as mobile phase For phase B, gradient elution was performed at a flow rate of 0.95 ml / min, a detection wavelength of 250 nm, and a column temperature of 40° C.; the gradient elution process was the same as in Example 1.
[0063] Sample preparation:
[0064] Test solution: Take about 50 mg of azilsartan test product, weigh it accurately, put it in a 50ml measuring bottle, add an appropriate amount of methanol to dissolve and dilute to the mark, shake well, and use it as the sample solution.
[0065] Test operation: Take 10 μl of the test solution and inject it, and record the chromatogram.
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