Nanocomposite Detection of Elemental Impurities and Process Correlation Analysis of Ceftriaxone Sodium for Injection

Abstract

An inductively coupled plasma spectroscopy method was established to detect 29 elemental impurities in ceftriaxone sodium for injection by nanocomposite, and also used to detect the elemental impurities in the generic, domestic original and foreign original ceftriaxone sodium for injection. This paper for the first time analysed the possible sources of elemental impurities and their potential impacts on the drug quality based on the process. The results showed that zinc and potassium were detected in both the generic drug and the domestic original ceftriaxone sodium for injection, and zinc was not detected but potassium was detected in the foreign original drug; the content of zinc in the generic drug was significantly higher than that in the domestic original drug, and the content of potassium in generic drug and domestic original drug was higher than that in the foreign original drug, according to the process, the elemental impurities may come from the activated carbon or nanocarriers used in the process, and further stability analysis of the samples showed that the stability of the generic drug was slightly lower than that of the original drug, so it was speculated that impurity elements might also be one of the reasons for its instability.