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目的:建立HPLC法测定甲麻芩苷那敏片中盐酸甲基麻黄碱、马来酸氯苯那敏和黄芩苷含量的方法。方法:采用Shim-pack C18(4.6 mm×150 mm,5μm)色谱柱,甲醇-0.05 mol.L-1磷酸二氢钾溶液(用磷酸调pH至2.5)为流动相,梯度洗脱,流速1.0mL.min-1,检测波长220 nm,柱温30℃。结果:盐酸甲基麻黄碱、马来酸氯苯那敏和黄芩苷线性范围分别为0.654 5～6.545μg(r=0.999 9),0.020 52～0.205 2μg(r=0.999 8),0.656 5～6.565μg(r=0.999 9)。平均加样回收率(n=6)分别为100.8%(RSD为0.5%)、99.6%(RSD为0.8%)、99.3%(RSD为0.3%)。结论:本法操作简便,专属性强,定量准确,可用于该制剂的质量控制。
Objective: To establish a method for the determination of methyl ephedrine hydrochloride, chlorpheniramine maleate and baicalin in mequindox sodium tablets by HPLC. METHODS: The mobile phase was a Shim-pack C18 column (4.6 mm × 150 mm, 5 μm) with a mobile phase of methanol-0.05 mol·L-1 potassium dihydrogen phosphate (adjusted to pH 2.5 with phosphoric acid) mL.min-1, detection wavelength 220 nm, column temperature 30 ℃. Results: The linear ranges of methyl ephedrine hydrochloride, chlorpheniramine maleate and baicalin were 0.654 5 ~ 6.545 μg (r = 0.999 9), 0.020 52 ~ 0.205 2 μg (r = 0.999 8), 0.656 5 ~ 6.565 μg (r = 0.999 9). The average recoveries (n = 6) were 100.8% (RSD 0.5%), 99.6% (RSD 0.8%) and 99.3% (RSD 0.3%), respectively. Conclusion: This method is simple, specific, accurate and can be used for the quality control of the preparation.