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A technology of vonoprazan fumarate and a detection method, which is applied in the field of analytical chemistry, can solve the problem of not finding a purity detection method, etc., and achieves the effects of simple operation and high sensitivity
Active Publication Date: 2018-04-20
ENANTIOTECH CORP
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[0003] At present, there is no relevant literature on the purity detection method of 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate And reports, in order to strengthen the quality control of 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate, it is necessary to develop other detection method
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Embodiment 1
[0042] A kind of detection method of 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate
[0043] 1. Instruments and testing conditions
[0044] Shimadzu LC-15C high performance liquid chromatograph, the chromatographic column is Agilent ZORBAX SB-phenyl (4.6*250mm, 5μm);
[0045] Injection volume: 5μl;
[0046] Flow rate: 1ml / min;
[0047] Column temperature: 30°C;
[0048] Detection wavelength: 254nm;
[0049] Mobile phase: mobile phase A 0.1% formic acid aqueous solution, mobile phase B acetonitrile, using gradient elution, the gradient elution conditions are: 0-30min: mobile phase A 70%, mobile phase B 30%; 30-30.01min : mobile phase A 5%, mobile phase B 95%; 30.01-35min: mobile phase A 70%, mobile phase B 30%;
[0050] Diluent: acetonitrile: water, its volume ratio is (40-60): 50;
[0051] Detector: UV detector.
[0052] 2. Experimental steps
[0053] Adopt high-performance liquid chromatography to detect, and the detection steps ar...
Embodiment 2
[0060] Take four batches of 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate products produced by the same production specification instruction, respectively For the test product 1-4, it is detected according to the detection method of Example 1, and the area normalization method is used to calculate the purity and its impurities. The test results are shown in the following table 1-4:
[0061] Table 1 is the detection result of test product 1
[0062]
[0063]
[0064] Table 2 is the detection result of test product 2
[0065]
[0066] Table 3 is the detection result of test product 3
[0067]
[0068] Table 4 is the detection result of test product 4
[0069]
[0070] The detection method of the present invention can detect 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methanone simply, accurately, quickly, efficiently and reliably The purity and impurity content of amine fumarate are highly sensitive, easy...
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Abstract
The invention discloses a detection method of Vonoprazan fumarate. The detection method comprises the following steps: using a high performance liquid chromatography instrument to detect and an area normalization method to perform quantitative analysis, and controlling chromatographic conditions to be that the chromatographic column is Agilent ZORBAX SB-phenyl; the injection volume is 5 to 10 [mu]l; the flow velocity is 0.8 to 1.2 ml/min; the column temperature is 25 to 35 DEG C; the detection wavelength is 250 to 300 nm; the mobile phase comprises a mobile phase A which is a 0.1% formic acidaqueous solution and a mobile phase B which is acetonitrile in a volume ratio of (5-70): (30-95); the diluent comprises acetonitrile and water in a volume ratio of (40-60): 50; the detector is a UV detector; the detection method of Vonoprazan fumarate, disclosed by the invention, can simply, accurately, rapidly, efficiently and reliably detect the purity and impurities of 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate, has very high sensitivity, is simple and convenient in operation, can realize complete separation, and further provides the basis for the research, development and quality detection of the compound.
Description
technical field [0001] The invention belongs to the technical field of analytical chemistry, and in particular relates to a detection method of vonoprazan fumarate. Background technique [0002] Vonoprazan fumarate, its chemical name is 5-(2-fluorophenyl)-N-methyl-1-(3-pyridylsulfonyl)-1H-pyrrole-3-methylamine fumarate , is a potassium ion competitive acid blocker (P-CAB) developed by Takeda Pharmaceutical Company. In vitro experiments have shown that the ability of the compound to inhibit the proton pump is 400 times that of lansoprazole, and its relative to Na + ,K + - The inhibitory selectivity of ATPase is more than 1000 times, which can effectively inhibit the secretion of gastric acid and has the advantage of long duration. The purity of the compound and the impurities contained therein will directly affect its function of suppressing acid and treating gastric acid-related diseases. [0003] At present, there is no relevant literature on the purity detection method ...
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