| 引用本文: | 张囡,周健鹏.HPLC测定盐酸达泊西汀片中的异构体[J].中国现代应用药学,2017,34(9):1309-1312. |
| ZHANG Nan,ZHOU Jianpeng.Determination of Isomer in Dapoxetine Hydrochloride Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(9):1309-1312. |
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| 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（250 mm×4.6 mm，5 μm），柱温：40℃，检测波长：293 nm，流速：1.0 mL·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。 |
| 关键词: 盐酸达泊西汀片剂 高效液相色谱法 光学异构体 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.09.020 |
| 分类号:R917.101 |
| 基金项目: |
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| Determination of Isomer in Dapoxetine Hydrochloride Tablets by HPLC |
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ZHANG Nan1, ZHOU Jianpeng2
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1.Tianjin Children's Hospital, Tianjin 300074, China;2.Tianjin Institute for Drug Control, Tianjin 300070, China
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| Abstract: |
| 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 mL·min-1, and the mobile phase consisted of n-hexane-isopropanol-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. |
| Key words: dapoxetine hydrochloride tablets HPLC isomer |
