| 甲磺酸罗哌卡因注射液的含量及有关物质测定 |
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| 引用本文： | 王峰,杨伟峰,郑金琪.甲磺酸罗哌卡因注射液的含量及有关物质测定[J].中国药业,2007,16(5):27-28. |
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| 作者姓名： | 王峰 杨伟峰 郑金琪 |
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| 作者单位： | 浙江省药品检验所,浙江,杭州,310004 |
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| 摘 要： | 目的建立一种用反相高效液相色谱法（RP—HPLC法）测定甲磺酸罗哌卡因注射液含量及有关物质的方法。方法色谱柱为Agilent Zorbax C8柱（150mm×4．6mm，5μm），流动相为用三乙胺调节pH值至5．4的0．015mol／L磷酸二氢钾-乙腈（75：25），检测波长为210nm，流速为1．0mL／min。结果甲磺酸罗哌卡因质量浓度在20．74～207．40μg／mL范围内与峰面积线性关系良好（r=0．9999），平均回收率为100．0％（n=9），RSD=0．91％。日内精密度（RSD〈0．5％）与日间精密度（RSD〈0．5％）良好，最低检测限为0．0104μg／mL。结论所用方法简便、快速，结果准确、可靠。
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| 关 键 词： | 甲磺酸罗哌卡因注射液 含量测定 有关物质 反相高效液相色谱法 |
| 文章编号： | 1006-4931（2007）05-0027-02 |
| 收稿时间： | 2006-08-10 |
| 修稿时间： | 2006-11-01 |
Determination of Content and Related Substances in Ropivacaine Mesylate Injection by RP- HPLC |
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| Wang Feng,Yang Weifeng,Zheng Jinqi.Determination of Content and Related Substances in Ropivacaine Mesylate Injection by RP- HPLC[J].China Pharmaceuticals,2007,16(5):27-28. |
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| Authors: | Wang Feng Yang Weifeng Zheng Jinqi |
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| Institution: | Wang Feng, Yang Weifeng, Zheng Jinqi ( Zhejiang Institute for Drug Control, Hangzhou, Zhejiang, China 310004) |
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| Abstract: | Objective A HPLC method was established for the determination of ropivacaine mesylate injection and its related substances. Methods The column was Agilent Zorbax C8 column （150 mm ×4.6 mm, 5 μm）.The mobile phase to adjust the pH value to 5.4 with triethylamine 0. 015 mol/L phosphate buffer-acetonitrile （75：25）. The detection wavelength was 210 nm. The flow rate was 1.0 mL/min. Results Standard curve was linear in the range of 20.74- 207.40 μg/mL and the correlation coefficient was 0. 999 9. The average recovery rate was 100.0% （ RSD = 0. 91%, n = 9）. The precision of intra - day （ RSD 〈 0. 5% ） and inter - day （ RSD 〈 0. 5% ） were good. The minimal detection range was 0.0104 μg/mL, Conclusion This method is simple, rapid and the result is accurate. |
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| Keywords: | ropivacaine mesylate injection content determination related substance RP- HPLC |
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