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Analysis of polymer impurities in ceftazidime raw materials and preparations
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Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU*, Chang-qin HU
Acta Pharmaceutica Sinica | 2020, 55(8) : 1889 - 1896
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Acta Pharmaceutica Sinica | 2020, 55(8): 1889-1896
Analysis of polymer impurities in ceftazidime raw materials and preparations
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Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU*, Chang-qin HU
Affiliations
  • National Institutes for Food and Drug Control, Beijng 102629, China
Published: 2020-08-12 doi: 10.16438/j.0513-4870.2020-0084
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To establish a method for the determination of polymer impurities in ceftazidime raw materials and preparations, a ceftazidime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for ceftazidime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.02 mol·L-1 phosphate buffer, methanol and acetonitrile. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, four polymer impurities were detected in the 25-45 min time range with good specificity, sensitivity and robustness, including two ceftazidime dimers, trimers, and derivatives. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in ceftazidime, and ceftazidime degradation solution can be used as suitable solution for analysis of ceftazidime polymers.

ceftazidime  /  polymer  /  impurity  /  column-switch LC-MSn  /  high performance size exclusion chromatography  /  β-lactam antibiotics
Jin LI, Shang-chen YAO, Li-hui YIN, Ming-zhe XU, Chang-qin HU. Analysis of polymer impurities in ceftazidime raw materials and preparations[J]. Acta Pharmaceutica Sinica, 2020 , 55 (8) : 1889 -1896 . DOI: 10.16438/j.0513-4870.2020-0084
Year 2020 volume 55 Issue 8
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doi: 10.16438/j.0513-4870.2020-0084
  • Receive Date:2020-02-04
  • Online Date:2026-01-21
  • Published:2020-08-12
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  • Received:2020-02-04
  • Revised:2020-04-17
Affiliations
    National Institutes for Food and Drug Control, Beijng 102629, China
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表12种不同金属材料的力学参数

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Number of
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Number of
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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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