用加校正因子的自身对照法检测兰索拉唑的有关物质的含量  

Assay of Related Substances in Lansoprazole with Correction Factor

作　　者：谭宏宇 高丽[2] 

机构地区：[1]黑龙江省食品药品监督管理局 [2]北京科信必成医药科技发展有限公司哈尔滨分公司

出　　处：《黑龙江医药》2012年第6期821-823,共3页Heilongjiang Medicine journal

摘　　要：目的:建立加校正因子的主成分自身对照法测定兰索拉唑的有关物质的含量。方法:采用C18色谱柱(250mm×4.6mm,5μm),以水-A液*(A液*:乙腈-水-三乙胺(160:40:1)混合液,用磷酸调节pH值至7.0)(60:40)为流动相,柱温30℃,检测波长285nm。测定杂质A、B、E相对于兰索拉唑的相对保留时间及校正因子,并计算其含量。结果:兰索拉唑、杂质A、B、E质量浓度分别在0.0904μg/ml～2.892μg/ml,0.0992μg/ml～1.650μg/ml,0.0966μg/ml～3.255μg/ml,0.1426μg/ml～2.468μg/ml范围内线性关系良好,r均达到0.999。杂质A、B、E相对于主成分兰索拉唑的相对保留时间分别为0.42,1.17,0.23。杂质A、B的校正因子均在0.9～1.1范围,杂质E校正因子为0.39。结论:本方法操作简单、准确可靠,重现性、分离效果好,灵敏度高,无需提供杂质对照品就能准确测定兰索拉唑杂质的有关物质。Objective ：To establish a method using the correction factor for the determination of the related substance in lansoprazole. Methods：The assay was carried out on a C18 column （ 250 mm ×4. 6 mm,5μm） with them obile phase of wa- ter - A juice ＊ （ A juice ＊ ：juice - water - triethylamine（ 160：40 ： 1 ） mixed liquor, cum orthophosphoric acid accommodation pH ad 7.0） （60：40）. The column temperature, the detection wave length set at 30℃ ,285nm. The relative retention time and the correction factor between impurities A,B,E and lansoprazole were determined. The relative retention time was used to de- termine the position of impurities A,B,E, the correction factor was used to determine the content of impurities A,B ,E in lan- soprazole. Results：Good linear relationships of impurities A,B,E were obtained over the concentration range of 0. 0904μg/ml - 2. 892v.g/ml,0. 0992μg/ml - 1. 650μg/ml,0. 0966μg/ml - 3.255μg/ml,0. 1426μg/ml - 2. 468μg/ml （ r = 0. 999 ）. The relative retention time between impurities A,B.E and lansoprazole was 0. 42,1.17,0. 23 ,the correction factor between impu- rities A,B and lansoprazole was 0. 9 - 1.1 ;the correction factor between impuritiy E and lansoprazole was 0. 39. Conclusion： This method was proved to be simple, accurate and reliable to determine the related substance of lansoprazole without standard substances of impurities A,B,E.

关 键 词：兰索拉唑 有关物质 相对保留时间 校正因子 

分 类 号：R927.1[医药卫生—药学]