HPLC法测定洛索洛芬银乳膏中洛索洛芬银的含量

摘要

目的:建立测定洛索洛芬银乳膏中洛索洛芬银含量的方法,为该制剂的质量控制提供参考.方法:采用高效液相色谱法.色谱柱为Diamonsil C18,流动相为甲醇-水-冰醋酸-三乙胺(55:45:0.1:0.1,V/V/V/V),流速为1.0 mL/min,检测波长为223 nm,柱温为30℃,进样量为20μL.结果:洛索洛芬银检测质量浓度线性范围为6.53~130.7μg/mL(r=0.9999);定量限为0.253μg/mL,检测限为0.076μg/mL;精密度、稳定性、重复性试验的RSD<2%;加样回收率为96.79%~103.68%(RSD=2.23%,n=9).结论:该方法操作方便、结果准确、重复性好,可用于洛索洛芬银乳膏中洛索洛芬银的含量测定.%OBJECTIVE:To establish a method for the content determination of loxoprofen silver in Loxoprofen silver cream, and provide reference for the quality control of the preparation. METHODS:HPLC was performed on the column of Diamonsil C18 with mobile phase of methanol-water-glacial acetic acid-triethylamine(55:45:0.1:0.1,V/V/V/V)at a flow rate of 1.0 mL/min,de-tection wavelength was 223 nm,column temperature was 30 ℃,and the injection volume was 20 μL. RESULTS:The linear range of loxoprofen silver was 6.53-130.7μg/mL(r=0.9999);the limit of quantitation was 0.253μg/mL,limit of detection was 0.076μg/mL;RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 96.79%-103.68%(RSD=2.23%, n=9). CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for the content determination of Loxo-profen silver cream.