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目的:建立检测中成药中人工合成色素的固相萃取-高效液相色谱(SPE-HPLC)分析方法。方法:样品利用聚酰胺固相萃取柱净化和富集后进行HPLC分析。采用资生堂C18色谱柱,以甲醇和0.02 mol·L-1醋酸铵为流动相进行梯度洗脱,检测波长:508 nm,柱温:30℃,进样量:10μl。结果:合成色素线性范围均为0.005~0.200μg(r=0.999 9),回收率分别为97.6%(RSD=1.3%,n=6)、97.0%(RSD=1.4%,n=6)和99.5%(RSD=1.4%,n=6)。结论:该方法操作简单,结果准确可靠,重复性好,适用于中成药中人工合成色素的检测。
Objective: To establish a SPE-HPLC method for the determination of synthetic pigments in proprietary Chinese medicines. Methods: Samples were purified by polyamide solid phase extraction (SPE) column and analyzed by HPLC. The sample was eluted with a mobile phase of methanol and 0.02 mol·L-1 ammonium acetate using a Shiseido C18 column with a detection wavelength of 508 nm and a column temperature of 30 ° C. The injection volume was 10 μl. RESULTS: The linear range of the synthetic color was 0.005-0.200 μg (r = 0.999 9). The recoveries were 97.6% (RSD = 1.3%, n = 6), 97.0% (RSD = 1.4%, n = 6) % (RSD = 1.4%, n = 6). Conclusion: The method is simple, accurate, reliable and reproducible. It is suitable for the determination of synthetic pigment in proprietary Chinese medicines.