Full
Outline
To establish a method for determination of polymer impurities in ceftazidime averbatan sodium for injection.
Ceftazidime averbatan sodium was dissolved by water to prepare polymer stock solution. High performance size exclusion chromatography method (HPSEC) and column switching-LC/MSn method were applied to separate and deduce the poor retention impurities in polymer stock solution, and the specificity of HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with C18 column, using gradient elution by phosphate buffer solution (pH 3.2)-acetonitrile-methanol, and the RP-HPLC method was validated.
Five polymers were identified in polymer stock solution, some small molecular impurities were also detected. Polymer impurities were liable to co-elute with small molecular impurities when using HPSEC method, which resulted in poor quantification accuracy and specificity. Four indicative polymer impurities were detected by RP-HPLC method with effective specificity, and no polymers related to averbatan sodium were detected.
HPSEC method is not suitable for the quality control of polymer impurities in ceftazidime averbatan sodium for injection, while the newly established RP-HPLC method is specific, which can effectively control the polymer impurities. The polymer impurities in the samples were all from ceftazidime, and averbatan sodium did not produce polymer impurities.
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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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