HPLC梯度洗脱法测定兰索拉唑含量和有关物质
任萃文
【期刊名称】《食品与药品》 【年(卷),期】2012(014)005
【摘要】目的 建立检测兰索拉唑含量及有关物质的方法.方法 采用C18柱(250 mm×4.6 mm,5μm)；流动相A为水,流动相B为乙腈-水-三乙胺( 160∶40∶1),用磷酸调节pH 7.0;梯度洗脱:0 min-40 min-50 min-51 min,流动相A∶B的比例为90∶10-20∶80-20∶80-90∶10；检测波长285nm.结果 兰索拉唑与各已知杂质及降解产物均良好分离,兰索拉唑在44.7～447μg/mL浓度范围内与峰面积呈良好的线性关系,最低检测限与最低定量限分别为2.3 ng与6.4 ng.结论 本方法检测兰索拉唑有关物质专属性强,检测含量精密度高.%Objective To establish a method for the determination of lansoprazole and it related substances. Methods The determination was carried out on a Diamonsil C18 (250mm×4.6nun, 5μm) column with pure water (mobile phase A)-acetonitrile: water: triethylamine (160:40:1, mobile phase B) adjusted to pH=7.0 by phosphoric acid as mobile phases. The gradient elution was performed as follows: Omin, 90% A; 40min, 20% A; 50min, 20% A; 51min, 90% A. The detection wavelength was 285 nm. Results The developed method could be used for the determination of lansoprazole, known impurities and its degradation products with a good resolution. The calibration curve of lansoprazole was in good linearity over the range of 44.7~447μg/mL. The limit of detection (LOD) and limit of
HPLC梯度洗脱法测定兰索拉唑含量和有关物质
