HPLC-ELSD法测定吉法酯片的含量  

HPLC-ELSD determination of gefarnate tablets

作　　者：严敏[1] 陈晓春[1] 刘海峰[1] 李晖[1] 

机构地区：[1]四川大学化学工程学院,成都610065

出　　处：《药物分析杂志》2010年第8期1541-1543,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定吉法酯片含量的分析方法。方法:高效液相色谱-蒸发光散射检测(HPLC-ELSD)法,色谱柱为Agi-lent ZORBAX SB-C18色谱柱(150mm×4.6mm,5μm);流动相为甲醇-乙腈(55∶45),流速1.0mL.min-1,柱温:30℃,蒸发光检测器(以空气为载气,流速2L.min-1,漂移管温度70℃)检测。结果:吉法酯质量线性范围0.416～2.080μg,r=0.9996;平均回收率为99.8%(n=9),检出限(S/N=3)为8.32ng。6个批次吉法酯片含量为11.53%～11.63%。结论:该法操作简便,灵敏度高,重复性好,是吉法酯片含量测定的有效方法。Objective：To establish a method for determination of gefarnate tablets.Method：HPLC-ELSD,system consisting of an Agilent ZORBA SB-C18 column（150 mm×4.6 mm,5 μm） and a mixture of methanol-acetonitrile （55：45） as the mobile phase was adopted and the flow rate was 1.0 mL·min-1.The column temperature was set at 30 ℃.ELSD was used as the detector（the air flow rate was 2.0 L·min-1,the temperature of drift tube was 70 ℃）.Results：The calibration curve of gefarnate was in the range of 0.416-2.080 μg,r=0.9996.The average recovery was 99.8%（n=9）.Detection limits （S/N=3） was 8.32 ng.The content of six batches of gefarnate tablets ranged from 11.53%-11.63%.Conclusion：This method possesses merits of good accuricy and reproducibility.It is an effective method for the determination of gefarnate tablets.

关 键 词：HPLC-ELSD法 吉法酯 含量测定 

分 类 号：R917[医药卫生—药物分析学]