反相高效液相色谱法测定重酒石酸间羟胺及其注射液的有关物质和含量  

RP-HPLC Determination of Related Substance and Content in Metaraminol Bitartrate and Its Injection

作　　者：田洁[1] 余倩[1] 车宝泉[1] 戴红[1] 

机构地区：[1]北京市药品检验所,北京100035

出　　处：《中国药学杂志》2010年第17期1316-1319,共4页Chinese Pharmaceutical Journal

摘　　要：目的采用反相高效液相色谱法测定重酒石酸间羟胺的有关物质及含量。方法采用Phenomenex Gemini C18色谱柱（4.6 mm×250 mm,5μm）;以甲醇-0.03%己烷磺酸钠溶液（用40%磷酸调pH值至3.0）（20∶80）为流动相;有关物质检测波长为220 nm,含量测定检测波长为272 nm;柱温：35℃;流速1.0 mL·min^-1;进样量20μL。结果有关物质最低检出限为0.6 ng,含量测定定量限为7.6 ng;含量测定线性范围为12.5-75.0μg.mL-1,r=0.999 9;重酒石酸间羟胺注射液的加样回收率为100.5%、100.8%和101.2%,RSD为0.5%（n=9）。结论本法简便快捷、准确,专属性好。OBJECTIVE To establish a RP-HPLC method for the determination of related substance and content in metaraminol bitartrate and its injection.METHODS Using a Phenomenex Gemini C18 column（4.6 mm×250 mm,5 μm）.The mobile phase consisted methanol-0.03% sodium hexanesul fonate（adjust the pH value to 3.0 with 40% phosphoric acid solution）（20∶80）.The detection wavelength of related substance was 220 nm,The detection wavelength of content was 272 nm.The column temperature was 35 ℃.Inject volume was 20 μL.RESULTS The low detection limit for the related substance of metaraminol bitartrate was 0.6 ng,the quantitative limit for the content of metaraminol mitartrate was 7.6 ng.The linear range for the content of metaraminol bitartrate was 12.5-75.0 μg· mL^-1,r=0.999 9.The recoveries of metaraminol bitartrate injection were 100.5%,100.8%,101.2%,and its RSD was 0.5%（n=9）.CONCLUSION The method is simple,rapid,accurate and is suitable for the determination of the metaraminol bitartrateans its related substanceds

关 键 词：重酒石酸间羟胺 高效液相色谱法 有关物质 含量测定 

分 类 号：R917[医药卫生—药物分析学]