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Isolation and characterization of a degradation product in leflunomide and a validated selective stability-indicating HPLC-UV method for their quantification

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Journal of Pharmaceutical Analysis 2015年第3期5卷 207-212页

作者： Balraj Saini Gulshan Bansal Department of Pharmaceutical Sciences and Drug Research Punjabi University

Leflunomide （LLM） is subjected to forced degradation under conditions of hydrolysis, oxidation, dry heat, and photolysis as recommended by International Conference on Harmonization guideline Q1A（R2）. In total, four degradation products （I-IV） were formed under different conditions. products I, II and IV were formed in alkaline hydrolytic, acidic hydrolytic and alkaline photolytic conditions. LLM and all degradation products were optimally resolved by gradient elution over a C18 column. The major degradation product （IV） formed in hydrolytic alkaline conditions was isolated through column chromatography. Based on its IH NMR, IR and mass spectral data, it was characterized as a British Pharmacopoeial impurity B. The HPLC method was found to be linear, accurate, precise, sensitive, specific, rugged and robust for quantification of LLM as well as product IV. Finally, the method was applied to stability testing of the commercially available LLM tablets.

关键词： Leflunomide Characterization Forced degradation degradation product HPLC-UV

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LC-ESI-MS分析两性霉素B降解产物

分析测试学报 2004年第Z1期23卷 12-14页

作者：牛长群祝仕清刘素彦华北制药集团新药研究开发中心河北石家庄050015

　　两性霉素B(amphotericin B)是一种常用的抗真菌抗生素[1],属于多烯大环内酯类化合物,化学性质不稳定,在生产和储存过程中容易发生多种降解反应,产生无活性甚至有毒性的降解物,直接影响产品质量和临床用药的安全,因此,研究该抗生素... 详细信息

　　两性霉素B(amphotericin B)是一种常用的抗真菌抗生素[1],属于多烯大环内酯类化合物,化学性质不稳定,在生产和储存过程中容易发生多种降解反应,产生无活性甚至有毒性的降解物,直接影响产品质量和临床用药的安全,因此,研究该抗生素降解物和降解途径,对防止产品降解、保证产品质量非常必要.……

关键词： LC - ESI - MS Amphotericin B degradation product

Characteristics and degradation Mechanism of Fomesafen

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Journal of Northeast Agricultural University(English Edition) 2018年第1期25卷 9-15页

作者： Tao Bo Qiao Yu-xin Ma Cheng-yi Shao Bai-hui Jie Bai College of Agricultural Northeast Agricultural University

High performance liquid chromatography(HPLC) was used to determine the degradation efficiency of bacteria 2 strain(B2 S) under different conditions, the optimum cultivation conditions for fomesafen degradation bacterium B2 S were as the followings: temperature 35℃; inoculation quantity 5%; p H 5.0; glucose content 0.5% and fomesafen concentration 10 mg · L-1. Under optimal conditions, B2 S degraded fomesafen within 72 h of fomesafen application, with a degradation rate of nearly 100%. High performance liquid chromatography-mass spectrometry(HPLC-MS) was used to analyze fomesafen degradation into microbial products. A more thorough understanding of microbial fomesafen degradation mechanisms was discussed. The pathway of fomesafen degradation by B2 S was also inferred herein.

关键词： fomesafen bacteria 2 strain(B2S) degradation rate degradation product

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LC-ESI-MS分析两性霉素B降解产物

LC-ESI-MS分析两性霉素B降解产物

气相色谱与气相色谱-质谱联用法对七氟醚降解产物的测定

2004年全国有机质谱学术交流会

作者：牛长群祝仕清刘素彦华北制药集团新药研究开发中心

两性霉素B(amphotericin B)是一种常用的抗真菌抗生素,属于多烯大环内酯类化合物,化学性质不稳定,在生产和储存过程中容易发生多种降解反应,产生无活性甚至有毒性的降解物,直接影响产品质量和临床用药的安全,因此,研究该抗生素降解物和... 详细信息

两性霉素B(amphotericin B)是一种常用的抗真菌抗生素,属于多烯大环内酯类化合物,化学性质不稳定,在生产和储存过程中容易发生多种降解反应,产生无活性甚至有毒性的降解物,直接影响产品质量和临床用药的安全,因此,研究该抗生素降解物和降解途径,对防止产品降解、保证产品质量非常必要。已有不少有关两性霉素B各种剂型稳定性的研究报道,Thoma K等研究报道了多烯类抗生素光稳定性结果,然而有关两性霉素B在酸、碱、加热、氧化和光照等条件下降解途径研究未见报道。由于直接分离鉴定各降解产物比较困难,本实验采用LC-MS在线分析手段,直接

关键词： LC - ESI - MS Amphotericin B degradation product

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气相色谱与气相色谱-质谱联用法对七氟醚降解产物的测定