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Studies on the degradation impurity of linezolid tablets by UFLC-MS/MS
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Yin-ping LEI, Bo JIN, Tong LI, Ting-ting ZHANG, Chen MA*
Acta Pharmaceutica Sinica | 2017, 52(6) : 971 - 976
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Acta Pharmaceutica Sinica | 2017, 52(6): 971-976
• ORIGINAL ARTICLES·Pharmaceutical Analysis •
Studies on the degradation impurity of linezolid tablets by UFLC-MS/MS
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Yin-ping LEI, Bo JIN, Tong LI, Ting-ting ZHANG, Chen MA*
Affiliations
  • Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
Published: 2017-06-12 doi: 10.16438/j.0513-4870.2017-0047
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A method of ultra flow liquid chromatography-tandem mass spectrometry (UFLC-MS/MS) was developed to elucidate the impurity of linezolid tablets. Linezolid was subjected to forced degradation under hydrolytic (acid, base and neutral), oxidative, photolytic and thermal. The structure identification of the degradation products and the fragmentation patterns for the related impurities were analyzed. A total of four degradation impurities were characterized, impurity 1 is (S)-1-amino-3-((3-fluoro-4-morpholinophenyl)amino)propan-2-ol, impurity 2 is (S)-4-(4-(5-(acetamidomethyl)-2-oxo-oxazolidin-3-yl)-2-fluorophenyl)morpholine 4-oxide, impurity 3 is (S)-5-(aminomethyl)-3-(3-fluoro-4-morpholinophenyl)oxazolidin-2-one, impurity 4 is (R)-N-(3-((3-fluoro-4-morpholinophenyl)amino)-2-hydroxypropyl)acetamide. Acid degradation induced impurity 3 and impurity 4, base degradation induced impurity 1 and impurity 4, oxidation degradation induced impurity 2, hydrolysis degradation induced impurity 4. The study also determined calibration factor using impurity references, and the calibration factors were found to be 1.3, 1.4, 0.9 and 1.1, respectively. The toxicity of the degradation impurities was predicted by web-based prediction system. The results from this study provide an important reference in quality control and evaluation of linezolid.

linezolid  /  UFLC-MS/MS  /  degradation impurity  /  calibration factor  /  toxicity prediction
Yin-ping LEI, Bo JIN, Tong LI, Ting-ting ZHANG, Chen MA. Studies on the degradation impurity of linezolid tablets by UFLC-MS/MS[J]. Acta Pharmaceutica Sinica, 2017 , 52 (6) : 971 -976 . DOI: 10.16438/j.0513-4870.2017-0047
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Article Info
doi: 10.16438/j.0513-4870.2017-0047
  • Receive Date：2017-01-25
  • Online Date：2026-01-14
  • Published：2017-06-12
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  • Received：2017-01-25
  • Revised：2017-03-16
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    Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China
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表12种不同金属材料的力学参数
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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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