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| 硫酸卡那霉素注射液中有关物质测定方法研究 | |
| 引用本文： | 李玉林,陈真文,周玲,毛先兵,冉隆富. 硫酸卡那霉素注射液中有关物质测定方法研究[J]. 中国药业, 2011, 20(10): 41-43 |
| 作者姓名： | 李玉林 陈真文 周玲 毛先兵 冉隆富 |
| 作者单位： | 西南药业股份有限公司,重庆,400038 |
| 摘 要： | 目的采用高效液相色谱-蒸发光散射检测器(HPLC-ELSD)法测定硫酸卡那霉素注射液中有关物质。方法采用ZorbaxSB-C18柱(250 mm×4.6 mm,5μm),以0.2 mol/L三氟醋酸溶液-甲醇(95∶5)为流动相,流速为1.0 mL/min,柱温为室温,用蒸发光散射检测器检测(漂移管温度为80℃,载气压力为1.0 bar)。结果以对照溶液质量浓度的对数值与相应峰面积的对数值计算回归方程,其相关系数(r)均大于0.999,二者线性关系良好。结论高效液相色谱-蒸发光散射检测器法简便、准确、专属、灵敏。 |
| 关 键 词： | 高效液相色谱-蒸发光散射检测器法 卡那霉素 有关物质 硫酸卡那霉素注射液 |
Determination of Related Substances in Kanamycin Sulfate Injection by HPLC-ELSD |
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| Li Yulin,Chen Zhenwen,Zhou Ling,Mao Xianbing,Ran Longfu. Determination of Related Substances in Kanamycin Sulfate Injection by HPLC-ELSD[J]. China Pharmaceuticals, 2011, 20(10): 41-43 | |
| Authors: | Li Yulin Chen Zhenwen Zhou Ling Mao Xianbing Ran Longfu |
| Affiliation: | Li Yulin,Chen Zhenwen,Zhou Ling,Mao Xianbing,Ran Longfu(Southwest Pharmaceutical Co.,Ltd.,Chongqing,China 400038) |
| Abstract: | Objective To establish a HPLC-ELSD method for the determination of the related substances in Kanamycin Sulfate Injection.Methods The HPLC system consisted of the C18 chromatographic column（250 mm×4.6 mm,5 μm） and the mixture of 0.2 mol/L trifluoroacetic acetic acid-methanol（95 ∶5） as the mobile phase.The flow rate was 1.0 mL/min.The column temperature was the room temperature.The evaporative light scattering detector（ELSD） with the drift tube temperature of 80 ℃and carrier gas pressure of 1.0 bar was adopted for detection.Results The regression equation was calculated by the logarithm values of reference solution concentration and the corresponding peak area,the correlation coefficients（r） all were greater than 0.999,showing the good linear relationship between them.Conclusion This method is simple and accurate with good specificity and high sensitivity. |
| Keywords: | HPLC-ELSD kanamycin related substances kanamycin sulfate injection |
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