HPLC法同时测定复方阿魏酸钠阿司匹林胶囊中阿魏酸钠、桂利嗪、阿司匹林、维生素B₁

目的: 建立HPLC法同时测定复方阿魏酸钠阿司匹林胶囊中阿魏酸钠、桂利嗪、阿司匹林、维生素B₁的含量.方法: 采用Synergi 4u Hydro-RP 80 A C₁₈(250 mm×4.6 mm,5 μm)色谱柱,以甲醇-乙腈-pH 2.8醋酸溶液为流动相,梯度洗脱,流速1.0 mL·min^-1,检测波长270 nm,柱温25 ℃.结果: 阿魏酸钠、桂利嗪、阿司匹林、维生素B₁质量浓度分别在20.18~201.76、9.20~91.95、10.03~100.32、4.62~46.18 μg·mL^-1范围内呈良好的线性关系(r≥0.9996);低、中、高浓度平均回收率(n=3),阿魏酸钠为100.4%(RSD=0.8%)、99.9%(RSD=0.5%)、101.2%(RSD=0.9%),桂利嗪为100.6%(RSD=0.8%)、98.6%(RSD=0.7%)、98.4%(RSD=0.8%),阿司匹林为100.2%(RSD=1.2%)、98.2%(RSD=1.0%)、96.0%(RSD=1.1%),维生素B₁为99.7%(RSD=1.3%)、98.9%(RSD=1.1%)、96.7%(RSD=1.5%).结论: 本文方法简便、准确,适用于复方阿魏酸钠阿司匹林胶囊的质量评价.

Objective: To establish an HPLC method for four components(sodium ferulate, cinnarizine, aspirin, vitamin B₁)in compound sodium ferulate and aspirin capsules. Methods: The separation was performed on Synergi 4u Hydro-RP 80 A C₁₈ (250 mm×4.6 mm, 5 μm)column with the mobile phase of methanol-acetonitrile-pH 2.8 acetic acid water solution with gradient elution at the flow rate of 1.0 mL·min^-1, and the detection wavelength was 270 nm and the column temperature was 25 ℃. Results: The linear ranges of sodium ferulate, cinnarizine, aspirin and vitamin B₁ were 20.18-201.76 μg·mL^-1(r=0.9999), 9.20-91.95 μg·mL^-1(r=0.9999), 10.03-100.32 μg·mL^-1(r=0.9994)and 4.62-46.18 μg·mL^-1(r=0.9993), respectively.The average recoveries(n=3)of low, middle and high concentrations were 100.4%(RSD=0.8%), 99.9%(RSD=0.5%), 101.2%(RSD=0.9%)for sodium ferulate;100.6%(RSD=0.8%), 98.6%(RSD=0.7%), 98.4%(RSD=0.8%)for cinnarizine;100.2%(RSD=1.2%), 98.2%(RSD=1.0%), 96.0%(RSD=1.1%)for aspirin;and 99.7%(RSD=1.3%), 98.9%(RSD=1.1%), 96.7%(RSD=1.5%)for vitamin B₁. Conclusion: This method is simple, accurate, and suitable for the quality evaluation of compound sodium ferulate and aspirin capsules.