高效液相色谱法测定曲尼司特滴眼液中曲尼司特及其有关物质的含量-东南大学学报医学版

高效液相色谱法测定曲尼司特滴眼液中曲尼司特及其有关物质的含量

单位：1.中国药科大学制药有限公司,江苏南京,210009； 2.东南大学附属中大医院药剂科,江苏南京,210009

分类号：R927.2

出版年·卷·期（页码）：2008·27·第五期（365-367）

摘要：

目的:建立高效液相色谱法测定曲尼司特滴眼液中曲尼司特及其有关物质的含量.方法:以汉邦Lichrospher C18 (200mm×4.6mm,5μm)为色谱柱,以甲醇-0.02mol·L-1磷酸二氢钾溶液(用磷酸调节pH值至4.2)(60:40)为流动相,UV检测波长333nm,流速1.0ml·min-1.结果:曲尼司特在25～200mg·L-l范围内具有良好线性关系 (r=0.999 9),平均加样回收率为98.86%,RSD为1.10%;3批样品的标示百分含量(%)分别为99.57、100.17和99.87,有关物质的百分含量分别为0.52、0.56和0.55.结论:本方法准确、灵敏、重现性好,可用于曲尼司特滴眼液及其有关物质的含量测定.

Objective To establish the high performance liquid chromatography(HPLC) to determine tranilast and its related substances in tranilast eye drops.Methods The HPLC was performed on Lichrospher C18(200mm×4.6mm,5μm) column.The mobile phase consisted of methanol and 0.02mol·L-1 monobasic potassium phosphate buffer(60∶40).The flow rate was 1.0ml·min-1.The detection wavelength was set at 333nm.Results The assay showed good linear correlation over the range of 25-200mg·L-1(r=0.999 9).The average recovery was 98.86%,with the RSD=1.10%(n=9).The concentrations of tranilast in tranilast eye drops was 99.57%,100.17%,99.87% and the related compound in tranilast eye drops was 0.52%,0.56%,0.55%,respectively.Conclusion The HPLC is accurate,sensitive and repeatable with valuable application to the quality control of tranilast eye drops.

参考文献：

[1] 陈新谦, 金有豫, 汤光. 新编药物学, 2005
[2] KODA A, NAGAI H, WATANABE S. Inhibition of hypersensivity reaction by a new drug,N-(3,4-dimethoxycinamoly) anthranitic acid (N-5), 1976
[3] 杞晓红, 屠锡德. 曲尼司特缓释胶囊剂及其药物动力学研究. 中国药科大学学报1996(9)

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