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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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HPLC法快速检测苦参素注射液中8个抑菌剂及苯甲醛

HPLC rapid screening and simultaneous determination of eight bacteriostatic agents and benzaldehyde in oxymatrine injection

分类号:
出版年·卷·期(页码):2012,32 (7):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立快速筛查和同时测定苦参素注射液中8个抑菌剂(苯甲醇、苯酚、苯甲酸、山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯)及苯甲醇降解产物—苯甲醛含量的高效液相色谱法。 方法: 应用Welch Materials XB-C18色谱柱(4.6 mm×250 mm,5 μm),流动相为乙腈-0.02 mol·L-1醋酸铵溶液(冰醋酸调pH至5.0)梯度洗脱,流速1.0 mL·min-1,检测波长为211 nm(苯甲醇、苯酚),225 nm(苯甲酸),248 nm(苯甲醛),256 nm(山梨酸、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丁酯)。 结果: 9个成分的峰面积与浓度的线性关系良好(r﹥0.9998),加样回收率为95.6%~102.2%。 结论: 本方法灵敏,快捷,准确,重复性好,可用于注射剂中抑菌剂的快速筛查与含量分析。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish an HPLC method for rapid screening and simultaneous determination of eight bacteriostatic agents(benzyl alcohol, phenol, benzoic acid, sorbic acid, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate and benzaldehyde from degradation product of benzyl alcohol in oxymatrine injection. Methods: The analysis was performed on Welch Materials XB-C18 column(4.6 mm×250 mm,5 μm) with the mobile phase consisting of acetonitrile-0.02 mol·L-1 ammonium acetate(glacial acetic acid adjustable pH 5.0) in gradient mode. The detection wavelength was set at 211 nm for benzyl alcohol and phenol, 225 nm for benzoic acid, 248 nm for benzaldehyde and 256 nm for sorbic acid, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate. Result: Nine constituents showed good linearity(r﹥0.9998) in the range of the test concentration. The average recoveries of the method were between 95.6% and 102.2%. Conclusion: The method is sensitive, rapid and accurate with good repeatability, which can be used for rapid screening and determination of the content of bacteriostatic agents in injection.

-----参考文献:---------------------------------------------------------------------------------------
1 ChP(中国药典).2010.Vol Ⅱ(二部):Appendix(附录)ⅠB
2 WU Ting(武婷),WANG Chao(王超),WANG Xing(王星),at al.Determination of 24 preservatives in cosmetics by reversed phase high performance liquid chromatography(反相高效液相色谱法测定化妆品中的24种防腐剂).Chin J Anal Chem(分析化学),2007,35(10):1439
3 PANG Nan-nan(庞楠楠),MA-LIKE Dilnur(迪丽努尔·马力克),NIU Bei(牛蓓),et al.Determination of common preservatives in foods by fast gas chromatography(快速气相色谱法测定食品中的常见防腐剂).Chin J Anal Lab(分析实验室), 2005,24(3):48[JP]
4 GE Hai-sheng(葛海生),LIU Yuan-rui(刘元瑞),ZHAO Kan-hu(赵康虎). Content determination of bacteriostatic agent benzyl alcohol[JP] in clindamycin phosphate injection by HPLC(HPLC法测定克林霉素磷酸酯注射液中抑菌剂苯甲醇的含量). China Pharm(中国药房),2010,21(25):2376
5 LIAO Hai-ming(廖海明), LV Hai-hong(吕海鸿),XU Kang-sen(徐康森). RP-HPLC determination of phenol in ossotide injection(骨肤注射液中苯酚含量的RP-HPLC法测定).Chin J Pharm Anal(药物分析杂志),2005,25(4):397
6 EP 6.0. 1281
7 Akers MJ. The choice of preservatives for development of parenteral preparation(开发注射剂时抑菌防腐剂的选择). Foreign Med Sci(Sect Synthetic Drugs, Biochemical Drugs and Preparations)(国外药学-合成药、生化药、制剂分册),1986,7(1):33

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