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0.6,0.8,1.0,1.2,1.4μg/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1μg/L的杂质溶液,在室温下放置8 h,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。
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.
出处
《山西大同大学学报（自然科学版）》
2014年第3期41-43,46,共4页
Journal of Shanxi Datong University(Natural Science Edition)
基金
山西大同大学博士科研项目[H2012-B-22]
