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目的建立高效液相色谱(HPLC)法同时测定鼻用呋麻溶液中盐酸麻黄碱、呋喃西林及防腐剂羟苯乙酯的含量。方法色谱柱为Eclipse XDB-C_18柱(250 mm×4.6 nm×5μm);以甲醇-0.02 mol·L~(-1)磷酸二氢钾(用85%磷酸溶液调节pH3.0)-三乙胺(52∶48∶0.1)为流动相;流速为1 mL·min~(-1);柱温为40℃;检测波长为257 nm。结果盐酸麻黄碱在0.999 0~3.496 5 mg·mL~(-1)浓度范围内与峰面积线性关系良好,r=0.999 9(n=6),平均回收率为100.31%,RSD为0.30%(n=9);呋喃西林进样浓度在0.009 9~0.034 8 mg·mL~(-1)范围内与峰面积线性关系良好,r=0.999 9(n=6),平均回收率为100.00%,RSD为0.70%(n=9);羟苯乙酯进样浓度在0.014 8~0.051 8 mg·mL~(-1)范围内与峰面积线性关系良好,r=0.999 9(n=6),平均回收率为99.88%,RSD为0.41%(n=9);结论该法快速,准确,重复性好,可用于鼻用呋麻溶液的质量控制。
Objective To establish a high performance liquid chromatography (HPLC) method for simultaneous determination of ephedrine hydrochloride, nitrofurazone hydrochloride and preservatives in nasal furosemide solution. Methods The column was Eclipse XDB-C_18 (250 mm × 4.6 nm × 5 μm). The column was eluted with methanol-0.02 mol·L -1 potassium dihydrogen phosphate (adjusted to pH 3.0 with 85% phosphoric acid) -triethylamine (52:48:0.1) as mobile phase at a flow rate of 1 mL · min -1 .The column temperature was 40 ℃. The detection wavelength was 257 nm. Results Ephedrine hydrochloride had a good linear relationship with the peak area in the range of 0.999 0-3.4949 mg · mL -1, r = 0.999 9 (n = 6), with an average recovery of 100.31% and a RSD of 0.30% n = 9). The concentration of nitrofurazone was linear with the peak area in the range of 0.009 9-0.034 8 mg · mL -1, r = 0.999 9 (n = 6). The average recovery was 100.00% Was 0.70% (n = 9). The linear range of peak area was linear with the concentration of ethyl phenethyl ester in the range of 0.014 8-0.0518 mg · mL -1, r = 0.999 9 (n = 6) The recovery was 99.88% and the RSD was 0.41% (n = 9). Conclusion The method was rapid, accurate and reproducible and could be used for quality control of nasal furosemide solution.