高效液相色谱法测定盐酸阿扑吗啡鼻喷剂中阿扑吗啡的含量及有关物质  

Determination apomorphine hydrochloride and its relative substances in apomorphine hydrochloride nasal spray by HPLC

作　　者：徐世芳[1] 陈爱瑛[1] 姜丽霞[1] 

机构地区：[1]浙江省医学科学院药物研究所,杭州310013

出　　处：《中国现代应用药学》2006年第6期500-502,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 建立盐酸阿扑吗啡鼻喷剂的含量测定及有关物质检查方法。方法 采用高效液相色谱法，色谱柱为Diamonsil C18（5μm，4．6mm×150mm），流动相为乙腈-水-磷酸（16：84：0．4），流速1．0mL·min^-1，柱温30℃，UV 273nm检测。结果 盐酸阿扑吗啡在7．2～934μg·mL^-1（n=9）范围内线性关系良好（r=0．9999）；检测限为0．5ng，方法精密度RSD为0．8％（n=9）。3批样品盐酸阿扑吗啡的含量为标示量的98．0％～98．1％，有关物质含量为0．52％～0．68％。结论 本方法专属性强，灵敏度高，重现性好，操作简便；可用于该品的质量控制。OBJECTIVE To develop a method for the determination of apomorphine hydrochloride and its relative substances in apomorphine hydrochlofide nasal spray. METHODS Apomorphine hydrochloride and its relative substances were analysed on a Diamonsil C18 （5μm, 4.6mm×150mm） column. The mobile phase was CH3CN-H2O- H3PO4（ 16： 84：0.4） with the flow rate of 1.0 mL· min^-1. The column temperature was maintained at 30℃, and the detective wavelength was set at 273 nm. RESULTS The calibration cruve was linear in the range of 7.2 -934μg·mL^-1（ n = 9）, and the detection limit was 0.5ng. The method was repeatable with RSD 0.8% （ n = 9 ）. 3 batches of sample were analyzed and the apomorphine hydrochloride contents were 98.0% - 98.1% of the label amount, and the relative substances were 0.52% - 0.68%. CONCLUSION The method is simple, sensitive and reliable, which can be used for the quality control of this preparation.

关 键 词：盐酸阿扑吗啡 有关物质 含量测定 HPLC 

分 类 号：R917.780.1[医药卫生—药物分析学]