奶牛用利福昔明子宫注入剂有关物质反相高效液相色谱检测方法的建立及应用

doi:10.16431/j.cnki.1671-7236.2017.04.038

Abstract

Abstract:

The study was aimed to establish a method for detection of rifaximin related substances by reversed-phase high-performance liquid chromatography with UV detector. The instrument methods was WondaSil C18-WR 250 mm×4.6 mm 5 μm column, mobile phase was methanol∶acetonitrile∶3.16 g/L ammonium formate (concentrated aqueous ammonia adjusted to pH 7.2)=31.5∶31.5∶37, with detection wavelength 276 nm. Area normalization method was used to calculate the limit of detection, limit of quantification and concentration of rifaximin uterine injectant; The precision of the method, linear correlation and related substances specificity were explored. And the degradation degree of the peak area of the principal components was compared by the destruction of the extreme conditions, the content of the related substances and the separation degree. 40 to 150 μg/mL concentration of rifaximin, peak area and concentration showed a good linear relationship (R²=0.9998), the related substances concentration on peak area linear regression equation was y=23 510x+7 182, within a certain period of time after preparation of acids, alkalis, oxidation, high temperature degradation damage in varying degrees, in the main ingredient content in the sample before the damage was 100.00%, after oxidative damage and heat damage the main component was 13%, acids, alkalis destruction of the main component degradation was about 18%, the main component peak retention time was consistency before and after the destruction. The retention time and resolution of rifaximin and related-substance were good. (The separation between the main component peak and the impurity peaks were greater than 1.5, the degree of separation between the impurity peak and impurity peaks greater than 1.2). The substance detection methods of rifaximin uterine injectants was simple and had specificity and good repeatability, selective and sensitive, which could be used to analyze the related substance of rifaximin uterine injectants.

Key words: rifaximin; uterine injectants; related substance; HPLC; specificity

CLC Number:

S859.79⁺6

HUANG Hui-li, XU Fei, ZHANG Dao-kang, HUA Wei-yi, LI Xiu-bo, LIU Yi-ming. Establishment and Application of Reversed-phase High Performance Liquid Chromatography Method for Detection of Related Substances of Rifaximin Uterine Infusion in Dairy Cows[J]. , 2017, 44(4): 1211-1218.

References

[1] Sierra J M,Ruiz J,Navia M M,et al. In vitro activity of rifaximin against enteropathogens producing traveler's diarrhea[J]. Antimicrobial Agents & Chemotherapy,2001,45(2):643-644.
[2] Pistikli A,Galani I,Pyleris E,et al. In vitro activity of rifaximin against isolates from patients with small intestinal bacterial overgrowth[J]. International Journal of Antimicrobial Agents,2014,43(3):236-241.
[3] 刘妍,苏军凯,唐庆林,等. 利福昔明治疗肠易激综合征疗效的系统评价和Meta分析[J]. 胃肠病学和肝病学杂志,2015,24(3):287-290.
[4] 史同瑞,陈曦,王爽. 利福昔明及其在兽医临床中的应用[J]. 现代畜牧科技,2015,10:141-143.
[5] Infante R M,Ericeeon C D,Jiang Z D,et al. Enteroaggregative Escherichia coli diarrhea in travelers:Response to rifaximin therapy[J]. Clinical Gastroenterology & Hepatology the Official Clinical Practice Journal of the American Gastroenterological Association,2004,2(2):135-138.
[6] 周莹,欧阳五庆. 利福昔明纳米乳的制备及体外抗菌活性试验[J]. 畜牧与兽医,2012,S1:352-353.
[7] Gomi H,Jlang Z D,Adachi J A,et al. In vitro antimicrobial susceptibility testing of bacterial enteropathogens causing traveler's diarrhea,in four geographic regions[J]. Antimicrobial Agents & Chemotherapy,2001,45(1):212-216.
[8] 帅海涛,刘艳飞,彭东明,等. 利福昔明合成工艺的研究[J]. 应用化工,2013,42(10):1801-1803.
[9] 黄慧丽,徐飞,刘义明,等. 利福昔明的药理作用及其在奶牛疾病防治中应用的研究进展[J]. 中国畜牧兽医,2015,42(12):3358-3363.
[10] 赵文丽. 利福昔明治疗腹泻型肠易激综合征[J]. 国际药学研究杂志,2015,42(4):438-438.
[11] Gasztonyi B,Hunyadi B. Clinical and pharmacological aspects of rifaximin,local antibiotic therapy in intestinal disorders[J]. Orv Hetil,2004,145(43):2177-2181.
[12] Sun L,Dan L. Study on the depletion of rifaximin residue in milk[J]. Chinese Journal of Veterinary Drug,2013,47(9):27-30.
[13] Pigannelli S,Shurdhi A. Short communication:In vitro activity of rifaximin against Chlamydia suis[J]. Veterinary Record,2011,169(22):143-145.
[14] 余祖功,李晶,张海彬,等.家畜用利福昔明阴道栓剂及其制备方法[P].CN201110425645.6.2013.
[15] Yu Z G. Compound rifaximin dry suspension for preventing and treating endometritis of livestock and preparation method for same[P]. CN102512417 B. 2013.
[16] 曾庆艳. 浅析科学检验理念在食品药品检验工作中的价值[J]. 中国卫生标准管理,2014,5(11):102-103.
[17] 郑翔,尹松鹤. 药品检验的质量控制以及措施[J]. 生物技术世界,2015,6:275-275.
[18] 韦日伟,王昆,吴先富,等. 药物中有关物质检测方法的研究进展及应用[J]. 中国药师,2015,5:851-855.
[19] 刘拴娣,赵媛媛. 高效液相色谱法在抗生素药品有关物质分析中的应用[J]. 中国药业,2015,24(23):255-256.
[20] 孙鹤. 药物中有关物质检查方法的研究进展[J]. 求医问药,2011,9(7):10-11.
[21] 姜雄平,李慧义,陈桂良,等. 药品标准中有关物质HPLC测定的几点意见[J]. 中国药品标准,2013,14(3):163-167.
[22] 卢慧斌,肖静华. HPLC在药物分析中的应用[J]. 内蒙古科技与经济,2003,4:105-105.
[23] Rao R N,Nagaraju V. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs[J]. Journal of Pharmaceutical & Biomedical Analysis,2003,33(3):335-377.
[24] Olsen B A,Castle B C,Myer D P. Advances in HPLC technology for the determination of drug impurities[J]. Trac Trends in Analytical Chemistry,2006,25(8):796-805.
[25] Lee Y C. Method validation for HPLC analysis of related substances in pharmaceutical drug products[M]. America:John Wiley & Sons,Inc,2004.
[26] 申兰慧,石涛,赵春才,等. 利福昔明片的高效液相色谱分析[J]. 江苏药学与临床研究,2003,11(5):28-30.
[27] 孙拥军,杨运根. 反相高效液相色谱法测定利福昔明有关物质[J]. 安徽化工,2008,34(1):68-70.
[28] 秦川蓉,陆润钟. HPLC法测定利福昔明的含量与有关物质[J]. 中国抗生素杂志,2007,32(2):89-90.
[29] 施孝金. 《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》解读[J]. 上海医药,2016,37(7):16-17.
[30] 于海坤,孙大伟,孙园园. 化学药物杂质研究中色谱质谱技术应用分析[J]. 科技与创新,2016,18:146.
[31] 王维剑. 药品杂质控制与评价关键技术研究[D]. 济南:山东大学,2016.
[32] 赵庆华,赵豫,巩伟,等. 药物分析技术的应用研究新进展[J]. 中国医药指南,2016,14(10):39.

Establishment and Application of Reversed-phase High Performance Liquid Chromatography Method for Detection of Related Substances of Rifaximin Uterine Infusion in Dairy Cows

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