摘要
建立高效液相色谱法测定兰索拉唑片含量及有关物质的方法。方法采用C18色谱柱（4．6mm×250mm，5μm），以水-乙晴-三乙胺（60：40：1）用磷酸调pH7．0为流动相，流速：1．0mL·min^-1，检测波长为285nm，进样量20μL，柱温35℃。结果兰索拉唑浓度在19．76～177．84μg·mL^-1时，其峰面积与浓度的线性关系良好（r=1）；平均回收率为99．6％，平均相对标准偏差RSD为0．5％；检测限为0．02ng·mL^-1。结论本法快速、简便、准确，灵敏度高，适用于兰索拉唑片含量及有关物质测定。
OBJECTIVE To establish an HPLC method for the determination of the content and related substances of Lansuolazole Tablets. METHODS The HPLC system consisted of C18 column（4. 6 × 250mm, 5μm）, water-- acetonitrile-- triethylamine（60 ： 40 ： 1）,justed with phosphoric acid to a pH of 7.0 as mobile phase, the flow rate was 1.0mL .min^-1 Detection wavelength was set at 285nm, the injection volume was 20μL and column temperature was 35℃. RESULTS The calibration curve was linear in the range of 19.76- 177.84μg .mL^-1 （ r = 1） ;the average recoveries were 99. 6 % with corresponding RSD of 0. 5 % ;the limit of detection was 0.02ng . mL^-1. CONCLUSION The method was rapid,simple, accurate sen- sitive and suitable for the content and related substances determination of Lansuolazole Tablets.
出处
《齐鲁药事》
2009年第6期335-337,共3页
qilu pharmaceutical affairs
