HPLC法测定盐酸去甲替林的有关物质  

Determination of the Related Substances in Nortriptyline Hydrochloride by HPLC

作　　者：王海玲 孟黎明 丁阳[2] 

机构地区：[1]吉林省药物研究院,长春130060 [2]吉林大学白求恩医学部临床医学院

出　　处：《中国药师》2016年第2期399-401,共3页China Pharmacist

摘　　要：目的:建立测定盐酸去甲替林有关物质的HPLC方法。方法:色谱柱为Agilent C_(18)(250 mm×4.6 mm,5μm);流动相为乙腈-0.2%三乙胺(p H 3.0)(34∶66);检测波长为210 nm;流速为1.0 ml·min^(-1);柱温40℃;进样量为20μl。结果:各杂质峰与主峰分离度良好,检出限及定量限分别为0.40 ng及1.35 ng。结论:该方法灵敏度高、精密度好、专属性强,可用于盐酸去甲替林有关物质的测定。Objective： To establish a determination method for the related substances in nortriptyline hydrochloride by HPLC. Methods： An Agilent C18 （250 mm× 4.6 mm,5 μm） column was adopted with a mobile phase consisting of acetonitrile-0.2% trieth- ylamine（pH 3.0） （34 ： 66）. The flow rate was 1.0 ml· min-1 , the detection wavelength was set at 210 nm, the column temperature was 40℃ and the injection volume was 20 μl. Results： The resolutions of the related substances were acceptable. The detection limit and the quantitation limit of the samples was 0, 40 ng and 1.35 ng, respectively. Conclusion： The method is sensitive, accurate and specific, and can be used to determine the related substances in nortriptyline hydrochloride.

关 键 词：盐酸去甲替林 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]