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高效液相色谱法测定那他霉素的含量和有关物质

HPLC determination of content and related substances of natamycin
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摘要 目的:建立HPLC法测定那他霉素的含量和有关物质。方法:采用Diamonsil C18色谱柱(150mm×4.6mm,5μm);流动相:缓冲液(醋酸铵3.0g和氯化铵1.0g,加水760mL溶解并混匀)-乙腈-四氢呋喃(76:24:0.5);流速:1.5mL.min-1;检测波长:303nm;柱温:室温。结果:那他霉素浓度在100.136~1001.36μg.mL-1范围内线性关系良好(r=0.9999),最低检测限(S/N=3)为0.4ng。结论:本方法简便、灵敏、专属,重复性好,结果准确可靠,可用于测定那他霉素含量和有关物质。 Objective:To establish an HPLC method for the determination of content and related substances of natamycin.Methods:The analysis was carried out with Diamonsil C18 column(150 mm×4.6 mm,5 μm),using buffer(measure 3.0 g ammonium acetate and 1.0 g ammonium chloride,dilute with water to 760 mL)-acetonitrile-tetrahydrofuran(76:24:0.5) as mobile phase.The flow rate was 1.5 mL·min-1,the detection wavelength was set at 303 nm and the column temperature was room temperature.Results:The calibration curve for natamycin was linear in the rang of 100.136-1001.36 μg·mL-1.The detection limit(S/N=3) was 0.4 ng.Conclusion:The method is simple,sensitive,specific,reproducible,accurate and suitable for examination of the content and related substances of natamycin.
出处 《药物分析杂志》 CAS CSCD 北大核心 2010年第5期929-932,共4页 Chinese Journal of Pharmaceutical Analysis
关键词 那他霉素 HPLC 含量测定 有关物质 natamycin HPLC assay related substances
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参考文献3

  • 1USP 30 - NF 25. 2008. 2716. 被引量:1
  • 2ChP(中国药典)[M],VolⅡ(二部),2005:819 被引量:7
  • 3Validation & Verification of Quality Standard of Import Drug(进口药品注册标准).Natamycin eye drops(那他霉素滴眼液).No.JX20000157(标准号:JX20000157). 被引量:1

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