摘要
目的建立聚桂醇原料药含量测定的高效液相色谱法。方法采用十八烷基硅烷键合硅胶柱(4.6mm×150mm,5μm),以乙腈-甲醇-水(20∶68∶12)为流动相;流速为1.0mL.min-1;示差折光检测器;检测器和柱温均为35℃。结果聚桂醇在0.50~10.00g.L-1质量浓度范围内与峰面积呈良好的线性关系;回收率为99.2%(n=9),RSD为1.3%。结论该法简便准确,可用于聚桂醇原料药的质量控制。
Objective To establish an HPLC method for content determination of lauromacrogol in the crude drug. Methods A C18 column (4.6 mm ×150mm,5μm) was adopted with a mobile phase of acetonitrile-methanol-water (20 : 68 : 12), and the flow rate was at 1.0 mL·min^-1 with a differential refraction detector; the temperatures of the column and the differential detector were 35 ℃. Results Lauromacrogol was in a good linearity with the pick area within the range of 0. 50-10.00 g·L^-1, and the average recovery was 99.2% (n=9) with RSD of 1.3%. Conclusion The method is simple and accurate which can be used for the quality control of lauromacrogol.
出处
《中国药事》
CAS
2013年第6期617-619,共3页
Chinese Pharmaceutical Affairs