HPLC测定盐酸达泊西汀片中的异构体  

Determination of Isomer in Dapoxetine Hydrochloride Tablets by HPLC

作　　者：张囡[1] 周健鹏 

机构地区：[1]天津市儿童医院,天津300074 [2]天津市药品检验所,天津300070

出　　处：《中国现代应用药学》2017年第9期1309-1312,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立盐酸达泊西汀片剂中异构体的HPLC检测方法。方法采用DAICEL CHIRALPAK OZ-H色谱柱(250mm×4.6 mm,5μm),柱温:40℃,检测波长:293 nm,流速:1.0 m L·min-1,流动相:正己烷-异丙醇-二乙胺(80∶20∶0.05)。结果盐酸达泊西汀及其异构体在0.01~0.50 mg·mL^(-1)内具有良好的线性关系(r=0.999 9),盐酸达泊西汀定量限为0.002 mg·mL^(-1)(相当于0.02%),最低检测限为0.001 mg·mL^(-1)(相当于0.01%);异构体定量限浓度为0.001 mg·mL^(-1)(相当于0.01%),最低检测限为0.000 5 mg·mL^(-1)(相当于0.005%)。结论该方法操作简便,结果准确,可用于盐酸达泊西汀片剂中异构体的含量测定。OBJECTIVE To establish a method of HPLC for the determination of isomer in dapoxetine hydrochloride tablets. METHODS The column of DAICEL CHIRALPAK OZ-H（250 mm×4.6 mm, 5 μm） was used. Column temperature was 40 ℃, detection wavelength was 293 nm, flow rate was 1.0 m L·min-1, and the mobile phase consisted of n-hexaneisopropanol-diethylamine（80∶20∶0.05）. RESULTS The calibration curves of dapoxetine hydrochloride and isomer were linear over the range of 0.01-0.50 mg·mL^（-1）（r=0.999 9）. The limit of quantification was 0.002 mg·mL^（-1）（equivalent to 0.02%）. The minimum detection limit was 0.001 mg·mL^（-1）（equivalent to 0.01%）. The limit of quantification of isomer was 0.001 mg·mL^（-1）（equivalent to 0.01%）, and the minimum detection limit was 0.000 5 mg·mL^（-1）（equivalent to 0.005%） CONCLUSION The method is proved to be simple and accurate, which is suitable for the content determination of optical isomer in dapoxetine hydrochloride tablets.

关 键 词：盐酸达泊西汀片剂 高效液相色谱法 光学异构体 

分 类 号：R917.101[医药卫生—药物分析学]