������ɷ��칹�弰���й�����ͬʱ������ͽṹȷ֤

Simultaneous Separation and Detection of Principal Component Isomers and Related Substances in Ioversol Bulk Drug

??OBJECTIVE To establish a UPLC-MS method for the separation and detection of principal component isomers and related substances in ioversol bulk drug. METHODS The separation was performed on a Waters ACQUITY UPLC^TM BEH C₈ column (2.1 mm??100 mm,1.7 ??m), the mobile phase consisted of acetonitrile-0.1% formic acid in water (3:97),and the detection wavelength was set at 254 nm. The identification of isomers and impurities in ioversol bulk drug was performed with a triple-quadrupole mass spectrometer, with an electrospray ionization (ESI) source in the positive ion mode, and the cone voltage was set at 80 V. RESULTS The four optical isomers and related substances were seperated well, and their structures were confirmed by MS,UV, and RP-UPLC.The linear ranges of ioversol, impurity??, and impurity ?? were 0.5-52.8, 0.2-9.3, and 0.5-28.4 ??g??mL^-1, respectively (r=0.999 9); the detection limits of ioversol, impurity??, and impurity?? were 0.2, 0.08, and 0.2 ??g??mL^-1, respectively.CONCLUSION The method is simple, sensitive, and accurate, can be used to separate and determine the principal component isomers and related substances in ioversol bulk drug.