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目的建立感冒灵胶囊的质量标准。方法采用C18色谱柱,流动相为乙腈-0.03 mol·L-1磷酸氢二铵(磷酸调pH至3.1)(12∶88),进样量10μl,柱温为20℃,检测波长214 nm,流速为1.0 ml·min-1。结果对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在101.17～2 023.40、2.00～40.09和2.05～40.93 mg·L-1范围内线性关系良好,精密度RSD分别为0.05%、0.09%0、.17%(n=8),平均回收率分别为100.4%、99.6%、99.6%。结论结果准确,方法重复性好,可作为该制剂的质量控制指标。
Objective To establish the quality standard of Ganling capsule. Methods The mobile phase was acetonitrile-0.03 mol·L-1 diammonium phosphate (adjusted to pH 3.1 with phosphoric acid) (12:88) using a C18 column. The injection volume was 10 μl, the column temperature was 20 ℃, the detection wavelength was 214 nm, The flow rate was 1.0 ml · min-1. Results Acetaminophen, caffeine and chlorpheniramine maleate had good linearity in the ranges of 101.17 ~ 2 023.40, 2.00 ~ 40.09 and 2.05 ~ 40.93 mg · L-1 respectively. The RSDs of precision were 0.05%, 0.09 % 0, .17% (n = 8), the average recoveries were 100.4%, 99.6% and 99.6%, respectively. Conclusion The results are accurate, reproducible method can be used as the quality control indicators of the preparation.