曲安奈德新霉素贴膏中硫酸新霉素含量测定方法的建立

A method for determining neomycin sulfate in triamcinolone acetonide and neomycin paste

目的建立HPLC法测定曲安奈德新霉素贴膏中新霉素含量测定的方法。方法首先,通过正己烷溶解膏剂,水萃取的方法提取贴膏剂中的硫酸新霉素,然后建立HPLC法测定其含量,色谱条件为:Apolllo C18色谱柱(250mm×4.6mm, 5μm),流动相:0.1mol/L三氟醋酸溶液-乙腈(80:20,V/V),流速:0.5mL/min,进样量:20μL,柱温为30℃;蒸发光散射检测器:漂移管温度:80℃,载气流速:2.0L/min,增益为1。结果硫酸新霉素在1.0～5.0μg范围内,峰面积与样品浓度呈良好的log-log线性关系,线性方程为:Y=1.87X+7.12(r=0.999),定量限为:0.260μg,平均回收率为88.99%,重复性RSD为1.9%。结论所建立的方法简便、准确且快速,可用于曲安奈德新霉素贴膏中硫酸新霉素含量测定。

Objective To construct a method for determining neomycin sulfate in triamcinolone acetonide and neomycin paste by HPLC. Methods Firstly, dissolve the paste by n-hexane and then extract the neomycin sulfate in triamcinolone acetonide and neomycin paste by water. Secondly, determine the content of neomycin by HPLC on an Apolllo C18 column （250mm×4.6mm, 5μm） and 0. lmol/L trifluoroacetic acid in water-acetonitrile （80：20, V/V） as the mobile phase with the flow rate of 0.5mL/min. The injection volume was 20μL and the column temperature was set as 30℃. The evaporative light scattering detector was used with the drift tube temperature of 80℃, the carrier gas flow rate of 2.0L/min and the gain of 1. Results The peak area of neomycin showed good log-log linearity with concentrations in the range of 1.0-5.0~tg. The linear equation was Y=1.87X＋7.12 （r=0.999）, the detection limit was 0.260μg, the average recovery rate was 88.9%, and the RSD of repeatability was 1.9%. Conclusion The method was proved to be simple, accurate and quick, which was suitable for the assay of neomycin sulfate in triamcinolone acetonide and neomycin paste.