摘要
目的:建立注射用兰索拉唑含量及有关物质的反相高效液相色谱(RP-HPLC)测定法。方法:采用Agilent EclipseXDB-C_8色谱柱,三乙胺水溶液[取三乙胺10 ml,加水350 ml,以磷酸(1→10)调节pH至5.5[-甲醇(36:65)为流动相,流速:1.0 ml·min^(-1),检测波长284 nm。结果:兰索拉唑与杂质A、B、C、D、E的分离度均符合要求,系统适用性良好,兰索拉唑在0.303～2.725μg范围内线性关系良好,方法平均回收率为99.8%(RSD=0.64%)。结论:该法简便、准确,可用于注射用兰索拉唑的主药含量及有关物质测定。
To establish an HPLC method for determination of lansoprazole and related substances in Lansoprazole injection. Method：An Agilent Eclipse XDB-C_8 column was used with mobile phase of water solution of triethylamine（measure triethylamine 10ml,add water 350ml,then regelated pH to 5.5 with phosphoric acid solution）-methanol（36：65）.The flow rate was 1.0ml·min-land the detection wavelength was 284nm.Result：There was a good resolution between the lansoprazole and all the impurities （A,B,C,D,E）,and the system suitability was fine.It had a good linearity over the concertration range of 0.303-2.725μg.The average recovery was 99.8%with RSD of 0.64%.Conclusion：The method is accurate and convenient,can be used for determination of lansoprazole and related substances in Lansoprazole injection.
出处
《中国药师》
CAS
2013年第7期1079-1081,共3页
China Pharmacist
