盐酸马普替林片的含量测定及其有关物质研究  

RP-HPLC determination of maprotiline hydrochloride tablets and its related substances

作　　者：尹燕杰[1] 张启明[2] 白政忠[3] 安宁[2] 黄海伟[2] 

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150001 [2]中国药品生物制品检定所,北京100050 [3]黑龙江省药品检验所,哈尔滨150001

出　　处：《药物分析杂志》2008年第10期1661-1664,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立反相高效液相色谱法测定盐酸马普替林片的含量及有关物质,并利用LC-MS对其中的有关物质进行了初步分析。方法:色谱柱:ZORBAX Eclipse Plus C_(18)(250 mm×4.6 mm,5μm),流动相:水相[醋酸铵0.578 g,加水200 mL溶解后,加2 mL氨溶液(1→3)]-异丙醇-甲醇(36:12:52,pH:8.2～8.4),流速:1.0 mL·min^(-1),检测波长272 nm。结果:盐酸马普替林线性范围为0.099～4.943 mg·mL^(-1)(r=0.9999),最低检测限为10 ng,平均回收率(n=9)为100.4%;得到样品的相应色谱峰的ESI-MS质谱图,初步推断了其中杂质的结构。结论:所建立的方法能方便地分离测定盐酸马普替林片的含量及有关物质。Objective：To establish a RP-HPLC method for the determination of the content of maprotiline hydrochloride tablet and its related substances, and to analyze the related substances by LC - MS. Method ： The chromatographic column was ZORBAX Eclipse Plus C18（250 mm ×4.6 mm,5 μm）,the mobile phase consisted of aqueous phase （0. 578 g ammonium acetate in 200 mL water,2 mL ammonium solution） - isopropanol - methanol（36：12 ： 52,pH ：8.2 -8.4） at flow rate of 1.0 mL· min^-1 and detection wavelength was at 272 nm. Results：The linear ranges were 0.01 -5.00 mg· mL^-1（ r = 0. 9999）and the LOD was 10 ng. Average recoveries was 100.4% （n = 9 ） for maprotiline. Identify the structure of impurities by ESI - MS. Conclusion：The method proposed for determinations of the content and its related substances of maprotiline tablets is simple,rapid,specific and accurate.

关 键 词：反相高效液相色谱 盐酸马普替林 

分 类 号：R917[医药卫生—药物分析学]