HPLC梯度洗脱法测定兰索拉唑含量和有关物质

Determination of Lansoprazole and Its Related Substances by HPLC Gradient Elution Method

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×4.6mm, 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： 0min, 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 quantification （LOQ） of lansoprazole were 2.3ng and 6.4ng, respectively. Conclusion The method can be special for the detection of related substances and can be precise for the determination of lansoprazole.