摘要
目的建立盐酸莫西沙星氯化钠注射液有关物质检查的方法。方法采用苯基柱(4.6 mm×150 mm,5μm),流动相为乙腈-盐溶液(30∶70),检测波长为293 nm,流速为1.30 m L·min-1,柱温为30℃。结果莫西沙星与各已知杂质及降解产物均分离良好,系统适用性良好,杂质A、B、C、D、E线性良好。杂质B、杂质E校正因子分别为1.42、3.40。结论本方法检查盐酸莫西沙星氯化钠注射液有关物质专属性强、灵敏度高、准确可靠、重现性好。
Objective To establish a method for the inspection of related substances in Moxifloxacin Hydrochloride and Sodium Chloride Injection.Methods The determination was carried on a phenysilyl column（ 4.6 mm×150 mm,5 μm）with acetonitrile-saline solution（ 30 ∶ 70） as mobile phase. The detection wavelength was 293 nm. The flow rate was 1. 3m L·min-1,and the column temperature was 30 ℃.Results The developed method could be used for the determination of moxifloxacin,known impurities and its degradation products with a good resolution,the system suitability was fine.The impurities（ A,B,C,D,E） had good linearity.The corresponding correction factor： impurities B = 1.42,impurities E = 3.40.Conclusion The method can be special,sensitive and accurate with good reproducibility for the inspection of related substances in Moxifloxacin Hydrochloride and Sodium Chloride Injection.
出处
《药学研究》
CAS
2016年第9期529-531,555,共4页
Journal of Pharmaceutical Research
关键词
莫西沙星
有关物质
校正因子
Moxifloxacin
Related substances
Correction factor
