RP-HPLC法测定S-奥美拉唑钠及其有关物质的含量  

Determination of S-Omeprazole Sodium and the Related Substances by RP-HPLC

作　　者：胡晓[1] 唐小海[1,2,3] 谢永美[1] 杨丹[1] 霍晓方[1] 刘爱[1] 侯敬萍[1] 宋航[1] 

机构地区：[1]四川大学制药与生物工程系,成都市610065 [2]重庆莱美药业股份有限公司,重庆市401336 [3]四川省肿瘤医院,成都市610041

出　　处：《中国药房》2009年第22期1744-1746,共3页China Pharmacy

摘　　要：目的:建立以反相高效液相色谱法测定S-奥美拉唑钠及其有关物质含量的方法。方法:色谱柱为Phenomenex Luna C18,流动相为甲醇-0.033mol.L-1磷酸二氢铵-三乙胺(58:41.8:0.2,磷酸调pH值至7.0),检测波长为302nm,流速为1.0mL.min-1,柱温为25℃,进样量为20μL。结果:奥美拉唑钠检测浓度的线性范围为10～500mg.L-1(r=0.9997);平均加样回收率为100.27%,RSD=0.74%;有关物质平均含量为0.42%。结论:该方法简便、准确、专属性好,可用于S-奥美拉唑钠及其有关物质的含量测定。OBJECTIVE： To establish an RP- HPLC method for content determinatioh of s- omeprazole sodium and its related substances. METHODS： The separation of s omeprazole sodium and the related substances was carried out on a Phenomenex Luna C18 column, the mobile phase consisted of methanol- 0.033 mol. L^-1 ammonium dihydrogen phosphatetriethylamine （58 ： 41.8 ： 0.2, adiusted to pH 7.0 by phosphate acid） . The detection wavelength was 302 nm, the flow rate was 1.0 mL .min^ -1, the column temperature was 25℃ , and the sample size was 20 μL. RESULTS： The linear range of omeprazole sodium was 10-500 mg.L^-1 （r = 0.999 7） . The average recovery rate was 100.27% （RSD = 0.74% ） . The average content of the related substances in samples was 0.42%. CONCLUSION： This method is simple, accurate, specific and applicable for content determination of s-omeprazole sodium and its related substances.

关 键 词：反相高效液相色谱法 S-奥美拉唑钠 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]