高效液相色谱法测定盐酸可乐定脉冲释药微丸胶囊的含量  

Determination of Clonidine Hydrochloride in Clonidine Hydrochloride Pulsatile Release Pellets Capsules by HPLC

作　　者：杨宗发[1] 江尚飞[1] 张荣发[1] 胡娟娟[1] 

机构地区：[1]重庆医药高等专科学校,重庆400030

出　　处：《中国药业》2012年第3期11-12,共2页China Pharmaceuticals

基　　金：重庆市教育委员会科学技术研究项目;项目编号:KJ092702

摘　　要：目的建立盐酸可乐定脉冲释药微丸胶囊中盐酸可乐定的含量测定方法。方法采用高效液相色谱法,色谱柱为Diamonsil C8柱(250 mm×4.6 mm,5μm),流动相为0.22%辛烷磺酸钠-甲醇-磷酸(500∶500∶1,用1 mol/L氢氧化钠溶液或磷酸调pH至3.0),流速为1.0 mL/min,检测波长为220 nm。结果盐酸可乐定质量浓度在10.24～122.88μg/L范围内与峰面积线性关系良好(r=0.999 2);盐酸可乐定的平均回收率为99.73%,RSD=0.60%(n=9)。结论该法灵敏快速、准确可靠,可作为盐酸可乐定脉冲释药微丸胶囊中盐酸可乐定的含量测定方法。Objective To establish an HPLC method for determination of clonidine hydrochloride in Clonidine Hydrochloride Pulsatile Release Pellets Capsules. Methods Chromatography was carried out on a column of the Diamonsil C8（250 mm ~4.6 mm,5 I.Lm）;mobile phase was 0.22% sodium octanesulfonate - methanol - phosphoric acid（500 ： 500 ： 1, pH = 3.0） ; flow rate was 1.0 mL/min and the detection wavelength was 220 nm. Results A good linearity of clonidine hydrocbloride was obtained within 10. 24- 122.88 μg/L（ r = 0. 999 2） ;the average recoveries of elonidine hydrochloride was 99.73% , RSD = 0. 60% , respectively （ n = 9）. Conclusion The method is simple, rapid, sensitive and accurate. It can be used to control quality of elonidine hydrochloride in Clonidine Hydroehloride Pulsatile Release Pellets Capsules.

关 键 词：盐酸可乐定 脉冲释药微丸胶囊 含量测定 

分 类 号：R927.2[医药卫生—药学] R972.4