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HPLC法测定盐酸度洛西汀的含量及有关物质
http://www.100md.com 《儿科药学杂志》 2000年第1期
高效液相色谱法;盐酸度洛西汀;含量;有关物质,,],高效液相色谱法;盐酸度洛西汀;含量;有关物质,[关键词]高效液相色谱法;盐酸度洛西汀;含量;有关物质,1仪器与试药,2方法与结果,3讨论,参考文献:
     [摘要] 目的:建立HPLC法测定盐酸度洛西汀的含量和有关物质。方法:采用ODS2C18(4.6 mm×250 mm,5 μm)色谱柱,流动相为0.025 mol/L磷酸二氢钾溶液乙腈甲醇(3∶2∶2),流速为1.0 mL/min,检测波长为290 nm。结果:在9.0~45.0 μg/mL范围内,色谱峰面积与浓度呈良好的线性关系,r=0.9999;回收率100.2%(RSD=0.75%,n=9),最低检测限4 ng/mL。结论:该法准确、简便、灵敏,可用于盐酸度洛西汀的含量测定及有关物质检查。

    [关键词] 高效液相色谱法;盐酸度洛西汀;含量;有关物质

    Determination of contents of duloxetine hydrochloride and its related substances with HPLC

    ZHUO Zhi1, WANG Qing2

    (1.Chongqing Institute For Drug Control, Chongqing 401121, China; 2. Chongqing Shenghuaxi Pharmaceupical CO. LTD, Chongqing 400061, China)

    [Abstract] Objective:To establish an HPLC method to detemine duloxetine hydrochloride and its related substances. Methods: A Diamonsil ODS2C18 column (4.6 mm×250 mm, 5 μm) was used with the mobile phase of 0.025 mol/L potassium dihydrogen phosphateacetonitrilemethol (3∶2∶2) at the detection wavelength of 290 nm. The flow rate was 1.0 mL/min. Results: The calibration curve was linear in the range of 9.0~45.0 μg/mL, r=0.9999. The average recovery was 100.2% (RSD=0.75%, n=9). The minimum detection amount of duloxetine hydrochloride was 4 ng. Conclusions: This method is accurate, simple and sensitive, and it can be used for the assay or related substances control of duloxetine hydrochloride. ......

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