| HPLC法测定盐酸莫西沙星注射液杂质含量及其稳定性 |
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| 引用本文： | 刘怀新,;周东丽,;句宝龙.HPLC法测定盐酸莫西沙星注射液杂质含量及其稳定性[J].雁北师范学院学报,2014(3):41-43. |
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| 作者姓名： | 刘怀新 ;周东丽 ;句宝龙 |
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| 作者单位： | [1]山西大同大学化学与环境工程学院,山西大同037009; [2]山西大学商务学院外语系,山西太原030031 |
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| 基金项目： | 山西大同大学博士科研项目[H2012-B-22] |
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| 摘 要： | 采用HPLC法检测盐酸莫西沙星注射液杂质含量,色谱柱是苯基硅烷键和硅胶色谱柱,以V甲醇∶V混合液=28∶72为流动相,检测流速是1.3 mL/min,波长是293 nm,柱温是45℃.混合液为0.5g/L四丁基硫酸氢铵,1.0g/L磷酸二氢钾和3.4g/L磷酸等体积混合.在已建立的色谱状况中,当所含杂质浓度处在0.6,0.8,1.0,1.2,1.4 μg/mL的范围时,其分别和对应峰面积可以保持良好的线性关系.对于1 μg/L的杂质溶液,在室温下放置8h,稳定性良好,满足盐酸莫西沙星注射液对杂质的稳定性要求.建立起的方法易操作,能够满足莫西沙星供试样测定使用.
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| 关 键 词： | 盐酸莫西沙星注射液 高效液相色谱法 杂质线性 杂质溶液稳定性 |
Determination and Stability of Related Substances in Moxifloxacin Hydrochloride Injection by HPLC |
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| Institution: | LIU Huai-xin, ZHOU Dong-li, JU Bao-long (1.School of Chemistry and Chemical Engineering, Shanxi Datong University, Datong Shanxi, 037009; 2. Foreign Language Department, Business College of Shanxi University, Taiyuan Shanxi, 030031) |
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| Abstract: | An HPLC method was established for the determination of related substance in moxifloxacin hydrochloride injection. the method was carried out on a Phenyl silane bonded silica gel chromatography column with a mobile phase consisting of methanolbuffer solution （tetrabutyl ammonium hydrogen sulfate 0.5g, KH2PO4 1.0g, H3PO4 3.4g in 1L of purified water ）（28：72） in the flow rate of 1.3ml/min. the detection wavelength was 293nm and column temperature was 45℃. The calibration curves were linear over the range of 0.6-1.4 μg / mLo Good chromatographic separation of moxifloxacin hydrochloride and its related substances were obtained. As a resuit, the established HPLC method is simple, and could be used for the determination of moxiflocain hydrochloride and its related substances. |
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| Keywords: | moxifloxacin hydrochloride injection HPLC the linear of impurity the solution stability of impurity |
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