Quality control method of related substances of methanesulfonic acid kukoamine B
A technology of picromide mesylate and a detection method, which is applied in the field of medicine, can solve the problem that there is no detailed research report on the quality control method of picromide B impurity, and achieve strict and accurate control
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Embodiment 1
[0130] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; mobile phase is methanol-20mM tetrabutylammonium bisulfate aqueous solution (15:85) (concentrated ammonia water adjusts pH3.0); column temperature is 30°C; detection wavelength 280nm; flow rate 1ml / min. Weigh 25 mg of picroamine mesylate, 2 mg each of impurity 1, impurity 2, and impurity 3, and place them together in a 25ml measuring bottle, add an appropriate amount of water to dissolve, add water to dilute to the mark, and shake well to obtain a system suitability solution. Amount of 10 μl was injected into the high-performance liquid chromatograph, and the chromatogram was recorded.
[0131] The separation between each chromatographic peak in the system trial test should meet the requirements, and the number of theoretical plates is not less than 2000 in terms of picromide mesylate B, wherein the relative retention time of impurity 1 is about 0.32; the relative ret...
Embodiment 2
[0136]Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; mobile phase is methanol-20mM tetrabutylammonium bisulfate aqueous solution (10:90) (concentrated ammonia water adjusts pH3.0); column temperature is 30°C; detection wavelength 280nm; flow rate 1ml / min. Weigh 25 mg of picroamine mesylate, 2 mg each of impurity 1, impurity 2, and impurity 3, and place them together in a 25ml measuring bottle, add an appropriate amount of water to dissolve, add water to dilute to the mark, and shake well to obtain a system suitability solution. Amount of 10 μl was injected into the high-performance liquid chromatograph, and the chromatogram was recorded.
[0137] The separation between each chromatographic peak in the system trial test should meet the requirements, and the number of theoretical plates is not less than 2000 in terms of picromide mesylate B, wherein the relative retention time of impurity 1 is about 0.32; the relative rete...
Embodiment 3
[0142] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; mobile phase is methanol-20mM tetrabutylammonium bisulfate aqueous solution (20:80) (concentrated ammonia water adjusts pH3.0); column temperature is 30°C; detection wavelength 280nm; flow rate 1ml / min. Weigh 25 mg of picroamine mesylate, 2 mg each of impurity 1, impurity 2, and impurity 3, and place them together in a 25ml measuring bottle, add an appropriate amount of water to dissolve, add water to dilute to the mark, and shake well to obtain a system suitability solution. Measure 10 μl and inject it into the high-performance liquid chromatograph, record the chromatogram, the separation degree between the chromatographic peaks in the system trial test should meet the requirements, the number of theoretical plates is not less than 2000 according to picroamine mesylate B, and the impurity 1 The relative retention time of impurity 2 is about 0.32; the relative retenti...
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