| HPLC法测定一种美司钠注射液含量及有关物质 |
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| 引用本文： | 李辉,陈鸣,伍伟聪,靳贵英,董凤祥,张东升.HPLC法测定一种美司钠注射液含量及有关物质[J].安徽医药,2012,16(6):757-759. |
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| 作者姓名： | 李辉 陈鸣 伍伟聪 靳贵英 董凤祥 张东升 |
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| 作者单位： | 广东省药品检验所,广东,广州,510180;广东省药品检验所,广东,广州,510180;广东省药品检验所,广东,广州,510180;广东省药品检验所,广东,广州,510180;广东省药品检验所,广东,广州,510180;广东省药品检验所,广东,广州,510180 |
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| 摘 要： | 目的建立并优化测定美司钠注射液含量及有关物质的高效液相色谱方法。方法以磷酸盐缓冲液-甲醇(665∶335,V/V),用稀释的磷酸溶液调节pH值至(2.3±0.1)为流动相,检测波长235 nm,柱温30℃,流速为1.0 ml.min-1,采用优化的高效液相色谱法(HPLC)法测定美司钠注射液含量及有关物质。结果美司钠在浓度为1.07～10.58 g.L-1范围内有良好的线性关系,相关系数为0.999 6,平均加样回收率为100.4%,RSD为1.0%。结论该方法操作简单、快速、准确,可用于美司钠注射液中有关物质的检测和含量测定。
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| 关 键 词： | 美司钠 有关物质 含量测定 高效液相色谱 |
Determination of components of Mesna injections by HPLC |
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| Institution: | LI Hui, CHEN Ming,WU Wei-chong, et al ( Guangdong Institute for Drug Control, Guangzhou 510180, China) |
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| Abstract: | Objective To establish an PLC method for determination of Mesna injections by HPLC. Methods A Phenomenex Luna col- umn packed with octadecylsilane bonded silica gel was used. Detection wavelength was 235 nm. The mobile phase consisted of a mixture of phosphate buffer and methyl alcohol pH（2.3 ±0. 1 ）. Gradient elution was used at a flow rate of 1, 0 ml per minute. The column tem- perature was 30℃. Results The calibration curve of ranitidine hydrochloride was linear within the range of 1.07 - 10.58 g · L^-1 （ r = 0.999 6）. Average recovery was 100.4%. The RSD of precision was 1.0%. Conclusion The method is simple, accurate and reproduci- ble,which can be used to control the quality of Mesna iniections. |
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| Keywords: | Mesna related substances content determination HPLC |
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