摘要
目的:建立以高效液相色谱法测定注射用兰索拉唑中主药及有关物质含量的方法。方法:色谱柱为Shim-packC18,流动相为甲醇-水-三乙胺-磷酸(620∶380∶5∶1·5),流速为1mL·min-1,检测波长为284nm,进样量为20μL。结果:兰索拉唑检测浓度的线性范围为16~320μg·mL-l(r=0·9999);平均回收率为100·0%(RSD=1·08%,n=9);有关物质含量均为0·147%。结论:该方法简便、快速、准确、重现性好,适用于该制剂的质量控制。
OBJECTIVE: To establish a RP-HPLC method for the determination of Lansoprazole and the related substances in Lansoprazole for injection. METHODS: The separation was performed on Shim-pack C18 column. The mobile phase consisted of methanol- water- triethylamine -phosphoric acid (620∶380∶5∶1.5) with a flow rate of 1.0mL·min-1,detection wavelength of 284 nm and sample size of 20μL. RESULTS: The calibration curve was linear in the range of 16～320μg·mL-1(r=0.999 9). The average recovery was 100.0%(RSD=1.08%,n=9)...
出处
《中国药房》
CAS
CSCD
北大核心
2007年第13期1013-1014,共2页
China Pharmacy
