| HPLC法测定盐酸曲美他嗪缓释片中有关物质 |
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| 引用本文： | 刘晓岚,;王红梅,;张轶华.HPLC法测定盐酸曲美他嗪缓释片中有关物质[J].国外医药(植物药分册),2014(11):1242-1244. |
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| 作者姓名： | 刘晓岚 ;王红梅 ;张轶华 |
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| 作者单位： | [1]四川省交通运输厅公路局医院,四川成都611731; [2]河北省药品检验研究院,河北石家庄050011 |
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| 摘 要： | 目的建立盐酸曲美他嗪缓释片中有关物质的高效液相色谱测定方法。方法采用Diamonsil C18色谱柱（250mm×4.6 mm,5μm）,流动相为0.012 mmol/L庚烷磺酸钠溶液（p H 3.5）–甲醇–乙腈（55∶36∶9）,体积流量为1.0 m L/min,柱温为30℃,检测波长为210 nm,进样量：20μL。结果在所选定的液相色谱条件下,有关物质与主药分离良好。盐酸曲美他嗪、杂质A、杂质B和杂质C的检出限分别为10.2、4.4、4.5、8.0 ng。结论该方法操作简单,重复性好,专属性强,可用于控制盐酸曲美他嗪缓释片中的有关物质。
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| 关 键 词： | 盐酸曲美他嗪缓释片 盐酸曲美他嗪 有关物质 高效液相色谱 |
Determination of related substances in Trimetazidine Dihydrochloride Modified Release Tablets by RP-HPLC |
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| Affiliation: | LIU Xiao-lan,WANG Hong-mei,ZHANG Yi-hua(1. Sichuan Province Transportation Department Highway Bureau Hospital, Chengdu 611731, China ;2. Hebei Institute for Drug Control, Shijiazhuang 050011, China) |
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| Abstract: | Objective To establish an RP-HPLC method for the determination of related substances in Trimetazidine Dihydrochloride Modified Release Tablets. Methods The separation was performed on a Diamonsil C18 column（250 mm×4.6 mm, 5 μm） with the mobile phase of 0.012 mmol/L heptane sulfonic acid sodium solution（p H 3.5）- methanol- acetonitrile（55∶36∶9）. The flow rate was 1.0 m L/min with injection volume of 20 μL, the temperature of column was set 30 ℃, and the detection wavelength was set at 210 nm. Results Trimetazidine dihydrochloride and its related substances could be completely separated under the conditions. The detection limits of trimetazidine dihydrochloride, impurities A, B, and C were 10.2, 4.4, 4.5, and 8 ng. Conclusion The method is simple, quick, accurate, and reliable, which can control the related substances in Trimetazidine Dihydrochloride Modified Release Tablets. |
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| Keywords: | Trimetazidine Dihydrochloride Modified Release Tablets trimetazidine dihydrochloride related substance HPLC |
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