ABSTRACT
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™ BEH C8 column (2.1 mm×100 mm, 1.7 μm), the mobile phase consisted of acetonitrile-0.1% formic acid in water (3:97), and the detection wave-length 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-UP-LC. The linear ranges of ioversol, impurity I, and impurity II were 0.5-52.8, 0.2-9.3, and 0.5-28.4 μg·mL-1, respectively (r=0.9999); the detection limits of ioversol, impurity I, and impurity II were 0.2, 0.08, and 0.2 μg·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.
ABSTRACT
BACKGROUND: During coronary angiography, some electrocardiographic changes occured due to contrast media, which do life threatening influences. METHODS: We compared the electrocardiographic changes which were induced by injection of three radiopaque contrast media during selective coronary angiography in 49 patients with chest pain. One of the contrast media was high osmolar ionic(Urografin_76) and the another was low osmolar ionic(Hexabrix) and the last was non-ionic(Ioversol). Electrocardiograms were obtained before, during and after selective coronary angiography. RESULTS: The changes of S-T segment or T were decreased in non-ionic group rather than high osmolar or ionic group. And there was significant Q-Tc interval prolongation among all three groups except comparision of low osmolar ionic contrast dye and non-ionic contrast dye in left coronary angiography. CONCLUSION: Non-ionic low osmolar contrast media was safer than high osmolar or ionic contrast medial because of lesser change of Q-Tc interval during selective coronary angiography.