HPLC-PDA法测定氟苯尼考注射液、柴胡注射液中非法添加培氟沙星、洛美沙星

Determination of Pefloxacin and Lomefloxacin in Florfenicol Injection and Bupleurum Injection by HPLC-PDA

关键词:  氟苯尼考注射液  柴胡注射液  培氟沙星  洛美沙星  峰纯度检查  光谱相似度检查  高效液相色谱法

Key words:  florfenicol injection  bupleurum injection  pefloxacin  lomefloxacin  peak purity test  spectrum similar test  HPLC

摘要:

建立了氟苯尼考注射液、柴胡注射液中非法添加培氟沙星、洛美沙星的HPLC-PDA检查方法。采用十八烷基硅烷键合硅胶为填充剂；以磷酸溶液-乙腈-甲醇(85.5:7.0:7.5)为流动相；二极管阵列检测器,提取波长为277 nm。通过液相色谱保留时间、峰纯度检查和光谱相似度检查对非法添加物进行确证。结果表明,该色谱条件下培氟沙星、洛美沙星与其他物质分离良好。培氟沙星在氟苯尼考注射液、柴胡注射液中的平均回收率分别为101.4%(RSD=0.2%)、100.0%(RSD=0.4%),洛美沙星在氟苯尼考注射液、柴胡注射液中的平均回收率分别为101.2%(RSD=0.1%)、99.8%(RSD=0.5%)。本方法简便、准确、可靠,可用于检查氟苯尼考注射液、柴胡注射液中非法添加的培氟沙星、洛美沙星。

Abstract:

A method for the determination of pefloxacin and lomefloxacin in florfenicol injection and bupleurum injection was developed by the high performance liquid chromatography with photo-diode array detector (HPLC-PDA). It was tested with C18 column, using phosphoric acid solution -acetonitrile -methanol (85.5:7.0:7.5) as the mobile phase. The extract wavelength was 277 nm. Retention time, peak purity test and spectrum similar test were used to identify pefloxacin and lomefloxacin. Results showed that pefloxacin, lomefloxacin and other materials were finely separated. The mean recoveries of pefloxacin in florfenicol injection and bupleurum injection were 101.4%(RSD=0.2%), 100.0%(RSD=0.4%), and the mean recoveries of lomefloxacin in florfenicol injection and bupleurum injection were 101.2%(RSD=0.1%), 99.8%(RSD=0.5%). In conclusion, the method is simple, accurate and reliable for the determination of pefloxacin, lomefloxacin in florfenicol injection and bupleurum injection.