A kind of detection method of ganirelix acetate
A ganirelix and detection method technology, applied in the field of drug analysis, can solve the problems of poor separation and difficult to remove, and achieve the effects of high accuracy, good accuracy and small error
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Embodiment 1
[0063] Weigh 21.52mg of Ganirelix acetate bulk drug, put it in a 100ml measuring bottle, dissolve it with 35% acetonitrile aqueous solution and dilute to the mark, shake it up as the test solution; accurately measure 1ml of the test solution, put it in a 100ml measuring bottle , dilute to the mark with 35% acetonitrile aqueous solution, shake well, and use it as a control solution; choose Waters SunFire TM C183.5μm4.6*150mm is used as a chromatographic column, mobile phase A: 100mM ammonium sulfate and 25mM sodium perchlorate aqueous solution (phosphoric acid adjusts the pH value to 2.1); mobile phase B: acetonitrile: water = 1:1 (phosphoric acid adjusts the pH value 2.1), the detection wavelength is 210nm; the flow rate is 0.8ml / min, the column temperature is 45°C, 6 needles are continuously injected according to the elution gradient in Table 1, and the chromatogram is as follows figure 1 , and the test results are shown in Table 2.
[0064] Table 1 Elution Gradient
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Embodiment 2
[0070] Weigh 21.05mg of Ganirelix acetate bulk drug, put it in a 100ml measuring bottle, dissolve it with 35% acetonitrile aqueous solution and dilute to the mark, shake it up as the test solution; accurately measure 1ml of the test solution, put it in a 100ml measuring bottle , dilute to the mark with 35% acetonitrile aqueous solution, shake well, and use it as a control solution; choose Waters XBridge TM BEH130C183.5μm4.6*150mm as a chromatographic column, mobile phase A: 100mM ammonium sulfate and 25mM sodium perchlorate aqueous solution (phosphoric acid to adjust the pH value to 2.1); mobile phase B: acetonitrile: water = 1:1 (phosphoric acid to adjust the pH value 2.1), the detection wavelength is 210nm; the flow rate is 0.8ml / min, the column temperature is 45°C, 6 needles are continuously injected according to the elution gradient in Table 3, and the chromatogram is as follows figure 2 , and the test results are shown in Table 4.
[0071] Table 3 Elution Gradient
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Embodiment 3
[0076] Weigh 20.87mg of this product, put it in a 100ml measuring bottle, dissolve it with 35% acetonitrile aqueous solution and dilute to the mark, shake well as the test solution; accurately measure 1ml of the test solution, put it in a 100ml measuring bottle, and use 35% Dilute the acetonitrile aqueous solution to the scale, shake well, and use it as a control solution; select Agilent Poroshell 120SB-C182.7μm4.6*150mm as the chromatographic column, mobile phase A: 100mM ammonium sulfate and 25mM sodium perchlorate aqueous solution (phosphoric acid to adjust the pH value to 2.1 ); mobile phase B: acetonitrile: water = 1:1 (phosphoric acid to adjust the pH value to 2.1), the detection wavelength is 210nm; the flow rate is 0.8ml / min, the column temperature is 45°C, and 6 needles are continuously injected according to the elution gradient in Table 5 , the chromatogram as image 3 , and the test results are shown in Table 6.
[0077] Table 5 Elution Gradient
[0078] ...
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