HPLC-UV/MS2法考察国产莫匹罗星软膏的杂质谱

建立了同时适合莫匹罗星软膏杂质谱定性和定量研究的HPLC-UV/MS2方法。采用Agilent zorbax SB-C8色谱柱,以四氢呋喃-0.1 mol·L^-1的乙酸铵溶液（28∶72）为流动相;检测波长240 nm;柱温35℃;流速1.0 mL·min-1;进样体积20μL。建立的色谱条件可以使莫匹罗星与相邻杂质基线分离,在0.50~200.0μg·mL^-1范围内线性关系良好（r=1.000）;检测限为4.26 ng。对13批不同有效期的莫匹罗星软膏进行了有关物质测定,从中检出了16个杂质,采用LC-MS对主要杂质结构进行了推定,其中5个杂质为EP报道的杂质,方法简便,结果准确。

Study on Impurity Profile of Domestic Mupirocin Ointment by HPLC-UV/MS2

An HPLC-UV/MS2 method for the study of impurity profile of mupirocin ointment was established. The method was carried out on an Agilent C 8 column with a mobile phase consisted of tetrahydrofuran and 0.1 mol·L^-1ammonium acetate solution（28∶72）. The detection wavelength was set at 240 nm and the column oven was maintained at 35℃. The flow rate was 1.0 mL·min^-1 and the injection volume was 20 μL. Mupirocin was completely separated from the impurities. The calibration curve of mupirocin was linear over the range of 0.50~200.0 μg·mL^-1with the correlation coefficient of 1.000. The detection limit was 4.26 ng for mupirocin. Thirteen batches of mupirocin ointment with different shelf-life were tested and 16 impurities in total were detected by UV spectrometer and MS and 5 of them were identified as impurities reported in EP. This method is convenient,accurate and suitable for the determination of related substances and the study of impurity profile of mupirocin ointment.