• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
XU Jie, HU Wenhui, GU Dongfei, HANG Taijun. Identification and determination of related substances in atropine sulfate with hyphenated technique[J]. Journal of China Pharmaceutical University, 2014, 45(4): 438-443. DOI: 10.11665/j.issn.1000-5048.20140410
Citation: XU Jie, HU Wenhui, GU Dongfei, HANG Taijun. Identification and determination of related substances in atropine sulfate with hyphenated technique[J]. Journal of China Pharmaceutical University, 2014, 45(4): 438-443. DOI: 10.11665/j.issn.1000-5048.20140410

Identification and determination of related substances in atropine sulfate with hyphenated technique

More Information
  • A specific ion-pairing HPLC method was developed for the determination of related substances in atropine sulfate. Their structures were identified by LC-MS/MS. HPLC separation was carried out on a Thermo BDS Hypersil C18 column with linear gradient elution by a mobile phase consisting of acetonitrile and phosphate buffer solution(containing sodium heptane-sulphonate, adjusting pH to 5. 0 with phosphoric acid). The flow rate was 0. 8 mL/min and UV detection wavelength was 225 nm. Atropine sulfate and its related substances can be completely separated under the established HPLC condition. And they were characterized by hyphenated chromatographic techniques with accurate mass determination using high resolution LC-TOF/MS methods as well as product MS spectra scanning through a volatile mobile phase. Twelve related substances were detected and identified as by-products from synthesis and degradations of atropine sulfate. Six of them were related substances from EP and the other six were unknown related substances. This newly established HPLC method is effective in the separation and identification of the related substances in atropine sulfate and the results are useful for its quality control and process optimization.
  • [1]
    Cherkaoui S,Mateus L,Veuthey J,et al.Development and validation of a capillary zone electrophoresis method for the determination of atropine,homatropine and scopolamine in ophthalmic solutions[J].J Chromatogr B,1997,696(2):283-290.
    [2]
    Ceyhan T,Kartal M,Altun ML,et al.LC determination of atropine sulfate and scopolamine hydrobromide in pharmaceuticals[J].J Pharm Biomed Anal,2001,25(3):399-406.
    [3]
    Jakabová S,Vincze L,Farkas Á,et al.Determination of tropane alkaloids atropine and scopolamine by liquid chromatography-mass spectrometry in plant organs of Datura species[J].J Chromatogr A,2012,1 232:295-301.
    [4]
    European Pharmacopoeia(欧洲药典)[S].7.0(第7版).Monographs:1 429-1 430.
    [5]
    Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia: part 2(中华人民共和国药典:二部)[M].Beijing:China Medical Science Press,2010:981-982.
    [6]
    Bitar Y, Holzgrabe U. Impurity profiling of atropine sulfate by microemulsion electrokinetic chromatography[J].J Pharm Biomed Anal,2007,44(3):623-633.
    [7]
    Kirchhoff C,Bitar Y,Holzgrabe U,et al.Analysis of atropine,its degradation products and related substances of natural origin by means of reversed-phase high-performance liquid chromatography[J].J Chromatogr A,2004,1 046(1):115-120.
    [8]
    The First Pharmaceutical Factory of Hangzhou.Synthesis process of atropine sulfate[J].Chin J Pharm(中国医药工业杂志),1972,8:15-17.
  • Related Articles

    [1]XIA Ying, LONG Jiayi, DAI Haoran, SHEN Mengyuan, GUO Hongli, HU Yahui, CHEN Feng. Determination of digoxin in human plasma by LC-MS/MS and its application in pediatric patients[J]. Journal of China Pharmaceutical University, 2021, 52(6): 719-724. DOI: 10.11665/j.issn.1000-5048.20210610
    [2]XIA Ying, GUO Hongli, HU Yahui, CHEN Feng. Therapeutic drug monitoring for monoclonal antibody:progress in the application of LC-MS/MS technique[J]. Journal of China Pharmaceutical University, 2021, 52(1): 122-128. DOI: 10.11665/j.issn.1000-5048.20210117
    [3]LIU Chaoyi, ZHANG Ge, HANG Taijun, WANG Lei, ZHANG Xiaofei, SONG Min. Identification of related substances in rivaroxaban by LC-MS[J]. Journal of China Pharmaceutical University, 2015, 46(4): 450-457. DOI: 10.11665/j.issn.1000-5048.20150411
    [4]YANG Youtian, MAO Baiyang, CHENG Lifei, SU Mengxiang, DI Bin. Identification of the related substances in telmisartan/amlodipine double layer tablets by LC-MS/MS[J]. Journal of China Pharmaceutical University, 2014, 45(1): 65-69. DOI: 10.11665/j.issn.1000-5048.20140111
    [5]ZHANG Lu, QIANG Shuping, ZHANG Yunjing, WANG Lei, ZHANG Xiaofei, HANG Taijun. Preliminary identification of the related substances in cisatracurium besylate for injection by LC-MS[J]. Journal of China Pharmaceutical University, 2013, 44(1): 65-72. DOI: 10.11665/j.issn.1000-5048.20130111
    [6]KONG Xing-xin, SHEN Wen-bin, WANG Li-yun, SHI Jin-fang, DI Bin, ZHANG Tao. Identification of the related substances in cefmetazole sodium by LC-MS/MS[J]. Journal of China Pharmaceutical University, 2012, 43(2): 170-176.
    [7]QIN Fang, DING Ya, HANG Tai-jun, SONG Min. Identification of the related substances in faropenem sodium by LC-MS/MS[J]. Journal of China Pharmaceutical University, 2011, 42(4): 342-347.
    [8]SI Qian, CHEN Yuan-cheng, HUANG Li-hua, CHENG Yu, HE Hua, LIU Xiao-quan. Determination of nebivolol in human plasma by LC-MS/MS and study of its pharmacokinetics on the Chinese[J]. Journal of China Pharmaceutical University, 2011, 42(2): 136-140.
    [9]TIAN Yuan, FENG Shu-dan, HUANG Mei-hua, ZHANG Zun-jian. LC-MS/MS determination of glucocorticoids illegally added into cosmetics[J]. Journal of China Pharmaceutical University, 2011, 42(1): 53-57.
    [10]Multiresidue determination of fluoroquinolones in eggs by solid-phase extraction-LC-MS/MS[J]. Journal of China Pharmaceutical University, 2010, 41(1): 60-65.
  • Cited by

    Periodical cited type(3)

    1. 胡彤,李爽,钟卫鸿. 基于酸信号转导系统的细菌耐酸机制及其应用. 生物工程学报. 2024(03): 644-664 .
    2. 吴晓妍,吴剑梅,傅丹丹,涂健,宋祥军,邵颖,祁克宗. hipA对禽致病性大肠杆菌生物学特性和致病性的影响. 西北农林科技大学学报(自然科学版). 2023(08): 11-18+28 .
    3. 郝雪雁,刘梦晓,韩紫依,房立霞,曹英秀. 大肠杆菌的耐酸机制及其改造研究进展. 微生物学通报. 2023(10): 4667-4680 .

    Other cited types(1)

Catalog

    Article views (1250) PDF downloads (2222) Cited by(4)

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return