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Objective: To establish a method for controlling polymer impurities in ceftizoxime sodium for injection. Methods: Ceftizoxime sodium was dissolved in phosphate buffer solution (pH 7.0) to prepare degradation solution. High performance size exclusion chromatography (HPSEC) and column switching-LC/MSn (CS-LC/MSn) were applied to separate and deduce the poor retention impurities in the degradation solution. The specificity of developed HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with a Phenomenex Gemini C18 column, using phosphate buffer solution (pH 7.0)-acetonitrile as mobile phase under a gradient elution program. The specificity of RP-HPLC method was assessed by two-dimensional chromatography (2D-HPLC) and CS-LC/MSn, and LLOD and LLOQ were also tested. Results: ceftizoxime dimer and the dimer's isomer were deduced in the degradation solution as well as 6 small molecular impurities. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, which made a poor quantification accuracy and specificity. Ceftizoxime dimer and the dimer's isomer were detected by RP-HPLC with a sufficient specificity. Conclusion: HPSEC method was not suitable for the quality control of polymer impurities in ceftizoxime sodium for injection, while the RP-HPLC method was specific, which can be applied for polymer impurities. Ceftizoxime degradation solution can be used to identify polymer peaks as the systematic suitability testing solution.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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