HPLC法测定洛索洛芬银乳膏中洛索洛芬银的含量
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篇名: HPLC法测定洛索洛芬银乳膏中洛索洛芬银的含量
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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20 μL。结果:洛索洛芬银检测质量浓度线性范围为6.53~130.7 μg/mL(r=0.999 9);定量限为0.253 μg/mL,检测限为0.076 μg/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。
ABSTRACT: 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, detection wavelength was 223 nm, column temperature was 30 ℃, and the injection volume was 20 μL. RESULTS: The linear range of loxoprofen silver was 6.53-130.7 μg/mL(r=0.999 9);the limit of quantitation was 0.253 μg/mL,limit of detection was  0.076 μg/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 Loxoprofen silver cream.
期刊: 2017年第28卷第6期
作者: 沈一唯,鄢寒,黄月英,石晓晴,卞俊
AUTHORS: SHEN Yiwei,YAN Han,HUANG Yueying,SHI Xiaoqing,BIAN Jun
关键字: 洛索洛芬银乳膏;洛索洛芬银;高效液相色谱法;含量测定
KEYWORDS: Loxoprofen silver cream; Loxoprofen silver; HPLC; Content determination
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