Method for detecting fumaric acid impurities related to chlorpheniramine maleate and preparation thereof
The invention relates to a method for detecting fumaric acid impurities related to chlorpheniramine maleate and a preparation thereof, which adopts high performance liquid chromatography, and the chromatographic conditions are as follows: a chromatographic column is a core-shell chromatographic colu...
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Format: | Patent |
Sprache: | chi ; eng |
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Zusammenfassung: | The invention relates to a method for detecting fumaric acid impurities related to chlorpheniramine maleate and a preparation thereof, which adopts high performance liquid chromatography, and the chromatographic conditions are as follows: a chromatographic column is a core-shell chromatographic column; the column temperature is 25-35 DEG C; a mobile phase A is a phosphoric acid aqueous solution; a mobile phase B is acetonitrile; the detection wavelength is 223 to 227 nm, and the flow velocity is 0.5 to 0.7 ml/min; the method comprises the following specific detection steps: step 1) preparing a system applicability solution and a test solution; 2) based on the chromatographic conditions, performing sample injection detection by adopting a high performance liquid chromatograph with an ultraviolet detector to obtain a system applicability solution spectrogram and a test solution spectrogram; and 3) carrying out qualitative and quantitative analysis on fumaric acid impurities according to the obtained system appl |
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