盐酸托莫西汀口服溶液的有关物质和含量测定方法研究  

Study on Related Substances and Content Determination Method of Atomoxetine Hydrochloride Oral Solution

作　　者：曾倩 吴雪英 王伟婷 段琪琳 金晶 黄志军 ZENG Qian;WU Xue-ying;WANG Wei-ting;DUAN Qi-lin;JIN Jing;HUANG Zhi-jun(College of Physiology,Wuhan University of Technology,Wuhan 430070,China;Jianmin Pharmaceutical Group Co.Ltd.Wuhan 430052,China;Drug Evaluation Center of Hubei Drug Administration,Wuhan 430060,China)

机构地区：[1]武汉理工大学化学化工与生命科学学院,湖北武汉430070 [2]健民药业集团股份有限公司,湖北武汉430052 [3]湖北省药品监督管理局药品审评中心,湖北武汉430060

出　　处：《海峡药学》2023年第1期51-57,共7页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸托莫西汀口服溶液中的有关物质和托莫西汀含量的测定方法。方法采用HPLC对制剂的有关物质及含量进行测定,有关物质检测中所用色谱柱为Agilent Extend C 18柱(4.6 mm×250 mm,5μm);流动相是正丙醇∶pH 3.0离子对溶液=(15∶85);柱温:30℃;流速:1.0 mL·min^(-1);检测波长:215 nm;进样量:10μL。含量测定中所用色谱柱为Agilent Zorbax SB C_(18)柱(4.6 mm×150 mm,5μm);流动相A为正丙醇∶pH 3.0离子对溶液=(10∶90),流动相B为正丙醇∶pH 3.0离子对溶液=(35∶65),梯度洗脱;柱温:40℃;其他色谱条件同有关物质。结果有关物质中各已知杂质(邻甲基苯酚、去甲基托莫西汀、N-甲基-3-苯基-3-羟基丙胺)在定量限~限度浓度的200%范围内具有良好的线性关系,回收率平均值分别为104.33%,100.90%,104.04%,RSD均小于10%(n=12)。含量测定中托莫西汀在测定浓度的60%~140%范围内具有良好的线性关系,回收率平均值为101.02%,RSD(n=9)=0.75%,小于2.0%。结论所建立的有关物质以及含量测定方法方便快捷、重复性好,能对制剂质量进行有效控制。OBJECTIVE To establish a method for the determination of related substances and the content of atomoxetine in atomoxetine hydrochloride oral solution.METHODS The related substances and contents of the preparation were determined by HPLC.In the detection of related substances,the chromatographic column was Agilent Extend C 18(4.6 mm×250 mm,5μm),the mobile phase was n-propanol∶pH 3.0 ion pair solution=(15∶85),the column temperature was 30℃,the flow rate was 1.0 mL·min^(-1),the detection wavelength was 215 nm,and the injection volume was 10μL.In the content determination,the chromatographic column was Agilent Zorbax SB C_(18)(4.6 mm×150 mm,5μm),the mobile phase A was n-propanol∶pH 3.0 ion pair solution=(10∶90),and the mobile phase B was n-propanol∶pH 3.0 ion pair solution=(35∶65),the gradient elution,the column temperature was 40℃,and other chromatographic conditions were the same as those of related substances.RESULTS The known impurities in the relevant substances(o-methyl phenol,demethyl atomoxetine,N-methyl-3-phenyl-3-hydroxypropylamine)have a good linear relationship in the range of limit of quantitation to 200%of the limit concentration.The average recoveries were 104.33%,100.90%and 104.04%respectively,and the RSDs were all less than 10%(n=12).In the content determination,atomoxetine has a good linear relationship in the range of 60%to 140%of the determined concentration,and the average recovery rate is 101.02%,RSD(n=9)=0.75%,less than 2.0%.CONCLUSION The established method for the determination of related substances and content is convenient,rapid and reproducible,which can control the quality of the preparation effectively.

关 键 词：盐酸托莫西汀 口服溶液 有关物质 含量测定 

分 类 号：R927[医药卫生—药学]