OBJECTIVE To establish an analytical method for the simultaneous determination of 17 elements in injectable latamoxef sodium and the migration of elements from vials.

METHODS  A mixture of 5% nitric acid and 0.01% Au element was used as the diluent. Sc, Ge, Te, and Bi were used as internal standards. Inductively coupled plasma mass spectrometry(ICP-MS) was performed with a plasma power of 1550 W and the carrier gas flow rate of 1.09 L·min⁻¹.

RESULTS  The 17 elemental impurities showed good linearity(r²>0.999 for all), with quantification limits ranging from 0.0014 to 4.8800 ng·mL⁻¹. The average recoveries ranged from 94.8% to 113.2%(n=9), with repeatability RSD≤1.9%(n=6) and precision RSD≤2.7%(n=6). The detection results indicated that the elemental impurity content in injectable latamoxef sodium from different manufacturers complied with the relevant requirements, while the extent of element migration from vials varied among different manufacturers.

CONCLUSION The method established in this study offers rapid analysis, minimal interference, and high sensitivity, enabling accurate quantification of elemental impurities in injectable latamoxef sodium. It also reveals that vials made from low borosilicate materials may cause element migration, suggesting that manufacturers should select safer and more stable packaging materials for injectable formulations.