摘要
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C_(18)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p H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·m L^(-1)、0.223~22.30μg·m L^(-1)、0.212~21.20μg·m L^(-1)、0.200~20.00μg·m L^(-1)、0.200~20.80μg·m L^(-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·m L^(-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。
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 .
出处
《海峡药学》
2016年第7期46-49,共4页
Strait Pharmaceutical Journal
