高效液相色谱法测定盐酸青藤碱控释微丸的含量  

Determination of sinomenine hydrochloride controlled-release pellets by HPLC

作　　者：张丽锋[1] 张淑秋[1] 

机构地区：[1]山西医科大学药学院临床药学教研室,太原030001

出　　处：《山西医科大学学报》2006年第7期720-722,共3页Journal of Shanxi Medical University

基　　金：山西省归国留学人员科研基金资助项目(2005029)

摘　　要：目的建立盐酸青藤碱控释微丸的含量测定方法。方法采用反向高效液相色谱法,流动相为乙腈和0.01 mol/L磷酸二氢钾溶液(20∶80);柱温:30℃;流速:1 ml/min;检测波长为264 nm。结果控释微丸中的辅料对青藤碱的测定无干扰。盐酸青藤碱在10-80μg/ml范围内线性关系良好,以盐酸青藤碱浓度(c)对峰面积(A)进行线性回归,方程为c=9.76×10-5A-3.38,r=0.999 9;日内、日间标准偏差均小于2%;平均回收率均在98.0%-102.0%之间。结论该方法的精密度、准确度、重现性均符合中国药典的规定,可用于盐酸青藤碱控释微丸制剂的含量测定及稳定性研究。Objective To establish a method for determining of sinomenine hydrochloride controlled - release pellets. Methods High performance liquid chromatography （HPLC） method was used with the mobile phase consisted of acetonitrile and 0.01 mol/L potassium dihydrogen phosphate solution（20 ： 80）. Column temperature was 30 ℃, flow rate of mobile phase was 1 ml/min and wavelength of detector was set at 264 nm. Results The excipients did not interfere with the determination of sinomenine. Linear range of sinomenine hydrochloride was 10 - 80μg/ml, c = 9.76 × 10^-5A - 3. 138, r = 0. 999 9, and RSD of precision was less than 2 %. Mean recovery was between 98.0 % - 102.0 %. Conclusion The precision, accuracy and reproducibility were fit for China Pharmacopeia. The method can be used to determine sinomenine hydrochloride controlled - release pellets and investigate the stability of the preparation.

关 键 词：盐酸青藤碱 微丸 色谱法 高压液相 含量测定 

分 类 号：R917[医药卫生—药物分析学]