马来酸曲美布汀胶囊有关物质的HPLC法测定

目的：建立了高效液相色谱法测定马来酸曲美他汀胶囊中的已知有关物质A、B、C、D、E。方法采用 C18色谱柱，以高氯酸缓冲液（含戊烷磺酸钠0．15％，用0．1％醋酸胺溶液调节pH值至3．75）∶乙腈（65∶35）为流动相，检测波长215nm（杂质A）、267nm。结果杂质A、B、C、D及E分别在1．005～20．10μg? mL －1、0．223～22．30μg? mL －1、0．212～21．20μg? mL －1、0．200～20．00μg? mL －1、0．200～20．80μg? mL －1范围内线性关系良好；平均回收率分别为101．2％、100．8％、101．5％、99．8％、99．3％，RSD分别为2．7％、1．2％、0．9％、1．8％、0．8％。最低定量限分别为2750．0、30．8、41．8、148．0、104．0 ng? mL －1。结论本方法准确、简便，可用于马来酸曲美布汀中有关物质的判定。

Determination of ReIated Substances in Trimebutine MaIeate CapsuIes by HPLC

ABSTRACT:OBJECTIVE An HPLC method was established for the determination of related substances in trime-butine maleate capsules , including known related substances A , B, C, D and E.METHODS A C18 column was used,in perchloric acid buffer ( containing 0.15%sodium pentane ,adjusted to pH 3.75 with 0.1%ammonium ace-tate solution ):acetonitrile ( 65∶35 ) as the mobile phase , at the detection wavelength of 215 nm ( impurity A ) and 267nm.RESULTS It was linear for related substances A ,B,C,D and E in the ranges of 1.005 ~20.10μg?mL-1 ,0.2230~22.30μg? mL-1 ,0.2120~21.20μg? mL-1 ,0.2000~20.00μg? mL-1 and 0.2000~20.80μg?mL-1 ,respectively.The average recoveries were 101.2%( RSD=1.7%) ,100.8%( RSD=1.2%) ,101.5%( RSD=0.9%) ,99.8%( RSD=1.0%) and 99.3%( RSD=0.8%) , respectively.The low limits of quantification were 2750.0,30.8,41.8,148.0,104.0 ng? mL -1.CONCLUSION The method is accurate,rapid,and suitable for the determination of related substaces in trimebutine maleate capsules .