| 反相高效液相色谱二极管阵列检测器测定盐酸度洛西汀原料的有关物质 |
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| 引用本文： | 梁伟,王如伟,夏亚君,徐洪明.反相高效液相色谱二极管阵列检测器测定盐酸度洛西汀原料的有关物质[J].中国药业,2006,15(15):36-37. |
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| 作者姓名： | 梁伟 王如伟 夏亚君 徐洪明 |
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| 作者单位： | 1. 宁波市天衡制药有限公司,浙江,宁波,315201
2. 浙江康恩贝制药股份有限公司,浙江,杭州,321100 |
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| 摘 要： | 目的 建立盐酸度洛西汀有关物质的反相高效液相色谱（RP—HPLC）测定法。方法采用Agilent ODS色谱柱，以乙腈-50mmol／L磷酸二氢钾（33：67）为流动相，检测波长为234mm。结果 盐酸度洛西汀与各合成中间体、降解产物的分离度及检测灵敏度均满足要求。盐酸度洛西汀、中间（dul-4，dul-5，dul-6）最小检出量分别为0．1224，0．8064，0．4156，0．2032ng（S／N=3）．二极管阵列检测器测盐酸度洛西汀峰纯度〉99．99％。结论 该方法简便、专属性强，结果准确。
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| 关 键 词： | 盐酸度洛西汀 有关物质 反相高效液相色谱 二极管阵列检测器 |
| 文章编号： | 1006-4931(2006)15-0036-02 |
| 收稿时间： | 08 7 2006 12:00AM |
| 修稿时间： | 08 17 2006 12:00AM |
RP- HPLC Diode Array Detector for Determinating of Related Substances of Duloxetine Hydrochloride |
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| Liang Wei,Wang Ruwei,Xia Yajun,Xu Hongming.RP- HPLC Diode Array Detector for Determinating of Related Substances of Duloxetine Hydrochloride[J].China Pharmaceuticals,2006,15(15):36-37. |
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| Authors: | Liang Wei Wang Ruwei Xia Yajun Xu Hongming |
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| Institution: | 1. Ningbo Team Pharmaceutical Co., Ltd., Ningbo, Zhefiang, China 315201; 2. Zhejiang Conba Pharmaceutical Co., Ltd., Hangzhou, Zhefiang, China 321100 |
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| Abstract: | Objective To establish a method for the determination of related substances in duloxetine hydrochloride. Methods Agilent ODS column was used. The mobile phase was acetonitrile - 50 mmol/L monopotassium phosphate(33 : 67). Detection wavelength was at 234 nm. Results Resolution and detectable sensitivity of each constituent in sample satisfied the determining demand of related substances. The limit of detection for duloxetine hydrochloride and its intermediate (dul -4, dul -5, dul -6) was 0. 122 4 ng,0. 806 4 ng,0. 415 6 ng,0. 203 2 ng (S/N = 3), respectively. The peakpurity of duloxetine hydrochloride by diode array detector was > 99. 99%. Conclusion This method is found to be simple, selective, effective. |
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| Keywords: | duloxetine hydrochloride related substances RP- HPLC diode array detector |
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