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To establish a method for determination of polymer impurities in penicillin sodium for injection.
Penicillin sodium was dissolved by water to prepare penicillin polymer stock solution. High performance size exclusion chromatography method (HPSEC) and column switching-LC/MSn method were used to separate and deduce the weak retention impurities in polymer impurity solution and the specificity of HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with a C18 column, using gradient elution by the mixed solution [phosphate buffer solution (pH 3.4)-methanol (72∶14)] and acetonitrile, and the RP-HPLC method was validated.
4 polymers, their isomers, one dimer degradation and some small molecular impurities were identified in the polymer impurity solution. Polymer impurities were liable to be co-eluted with small molecular impurities by HPSEC method, which resulted in poor quantification accuracy and specificity. 3 indicative polymer impurities were detected by RP-HPLC method with effective specificity, including 2 dimers produced by different polymerized patterns.
HPSEC cannot effectively control the polymer impurities of penicillin sodium for injection. The established RP-HPLC method has good specificity and high sensitivity for the determination of impurities in penicillin sodium polymer for injection.
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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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