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Outline
To establish a determination method of polymer impurities in cefoxitin sodium injection.
Cefoxitin sodium was dissolved in water to prepare stock solution of cefoxitin sodium polymer. High performance size exclusion chromatography (HPSEC, TSK-gel G2000SWxl) and column switching-LC/MSn were applied to separate and deduce the poor retention impurities in the stock solution and to evaluate the specificity of HPSEC method. A new RP-HPLC method for polymer analysis was established with a Shimadzu Inertsil Ph-3 column, using a gradient elution by phosphate buffer solution (pH 3.2)-acetonitrile-methanol, and the method was validated.
Several cefoxitin sodium polymers were identified in stock solution of cefoxitin sodium polymer, 4 small molecular impurities were also detected. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, making a poor quantification accuracy and specificity. Two indicative polymer impurities were detected by RP-HPLC method with an effective specificity.
HPSEC method was not suitable for the quality control of polymer impurities in cefoxitin sodium injection, while the new established RP-HPLC method was specific, which could effectively control the polymer impurities. Cefoxitin sodium polymer stock solution could be used to identify polymer peaks as the system suitability 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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