HPLC法测定抗痨散中芥子碱硫氰酸盐的含量  

HPLC method for determination of sinapine thiocyanate in anti-tuberculosis pulvis

作　　者：杜建红[1] 钟元高[1] 凃显琴 何德云[1] 

机构地区：[1]成都军区联勤部药品仪器检验所,成都610017 [2]成都军区八一骨科医院

出　　处：《西南国防医药》2018年第1期45-47,共3页Medical Journal of National Defending Forces in Southwest China

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ15-2)

摘　　要：目的建立医院制剂抗痨散中芥子碱硫氰酸盐含量测定的方法。方法依据《中国药典》2015年版一部通则高效液相色谱法(HPLC),以乙腈-0.08 mol/L磷酸二氢钾溶液(12:88)为流动相;色谱柱:岛津inertsustain C18(250 mm×4.6 mm,5μm);检测波长326 nm;进样量20μl。在此色谱条件下,检测抗痨散中芥子碱硫氰酸盐含量,并进行精密度、重复性、稳定性、回收率试验。结果在0.00509~0.08129 mg/ml范围内,芥子碱硫氰酸盐含量与峰面积呈良好的线性关系,精密度、重复性RSD分别为0.57%、1.53%;样品平均回收率为95.58%,RSD为1.70%。结论 HPLC法能准确监测抗痨散中芥子碱硫氰酸盐的含量。Objective To establish the method to determine the content of sinapine thiocyanate in the hospital preparation of anti-tuberculosis pulvis. Methods According to the high performance liquid chromatography （HPLC） described in Volume IV of Chinese Pharmacopoeia （2015）, the acetonitrile-0.08 mol/L potassium dihydrogen phosphate solution （12：88） was taken as the mobile phase; the Shimadzu inertsustain C18 column （250 mm×4.6 mm, 5 μm） was used; the detection wavelength was 326 nm and the injection volume was 20 μl. Under such chromatographic condition, the content of sinapine thiocyanate in the anti-tuberculosis pulvis was measured and tests were performed for the precision, repeatability, stability and recovery rate. ~ Within the range of 0.00509-0.08129 mg/ml, there was a good linear relationship between the content of sinapine thiocyanate and the peak area. The relative standard deviation（RSD） of precision and repeatability was 0.57% and 1.53% respectively; the average recovery rate of sample was 95.58% and the RSD was 1.70%. Conclusion The HPLC method can accurately monitor the content of sinapine thiocyanate in anti-tuberculosis pulvis.

关 键 词：抗痨散 芥子碱 硫氰酸盐 含量 测定 高效液相色谱 

分 类 号：R927[医药卫生—药学]