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| RP-HPLC测定盐酸胺碘酮注射液中的有关物质 | |
| 引用本文： | 沈建飞,徐刚,金春,苏晋.RP-HPLC测定盐酸胺碘酮注射液中的有关物质[J].山西中医学院学报,2009,10(2):29-30,34. |
| 作者姓名： | 沈建飞 徐刚 金春 苏晋 |
| 作者单位： | 1. 江苏省太仓市中医院,江苏,苏州,215400 2. 江苏弘惠医药有限公司,江苏,南京,210008 3. 江苏神龙药业有限公司,江苏,盐城,224200;江苏弘惠医药有限公司,江苏,南京,210008 |
| 摘 要： | 目的：建立RP-HPLC测定盐酸胺碘酮注射液中有关物质的方法。方法：采用十八烷基硅烷键合硅胶色谱柱，2％三乙胺（用磷酸调节pH4.0）-甲醇（20：80）为流动相，检测波长241nm，流速1.0mL／min，柱温为室温。结果：在5μg／mL-40μg／mL范围内，盐酸胺碘酮浓度与峰面积线性关系良好。结论：该方法操作简便、重现性好、灵敏度高、专属性强。可用于盐酸胺碘酮注射液的质量控制。 |
| 关 键 词： | 盐酸胺碘酮 反相高效液相色谱法 质量控制 |
Determination of Relevant Compounds in Amiodarone Hydrochloride Injection by RP-HPLC |
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| Shen Jianfei,Xu Gang,Jin Chun,Su Jin.Determination of Relevant Compounds in Amiodarone Hydrochloride Injection by RP-HPLC[J].Journal of Shanxi College of Traditional Chinese Medicine,2009,10(2):29-30,34. | |
| Authors: | Shen Jianfei Xu Gang Jin Chun Su Jin |
| Institution: | 1.Taicang Municipal Hospital of TCM;Suzhou Jiangsu 215400;2.Jiangsu Shenlong Pharmaceutical Co.;Ltd.;Yancheng Jiangsu 224200;3.Jiangsu Honghui Pharmaceutical Co.;Nanjing Jiangsu 210008 |
| Abstract: | Objective：To establish the method of detecting relevant compounds in amiodarone hydrochloride injection by RP-HPLC. Method：RP-HPLC was performed on ODS-2 C18 column （4.6mm×250mm,5μm）with 2% triethylamine： methanol （20：80）as mobile phase at flow rate of 1.0mL/min. The detection wavelength was 241 nm. Result：The liner range of amiodarone hydrochloride injection was 5 μg/mL-40μg/mL. Conclusion ：This method is easy,reproducibility, sensitivity and characteristic, which could be used to control the quality of amiodarone hydrochloride injection. |
| Keywords: | amiodarone hydrochloride RP-HPLC quality control |
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