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目的:建立高效液相色谱法同时测定盐酸阿普林定片含量和有关物质的方法。方法:色谱柱为Waters symmetry-C_(18),(150 mm×4.6 mm,5μm),流动相为甲醇-0.02 mol·L~(-1)磷酸二氢钾(用磷酸调节pH至3.0)(50:50,v/v),流速为1.0 ml·min~(-1),检测波长为254 nm,柱温为35℃,进样量为20μl。结果:盐酸阿普林定浓度在3.0~22.5μg·ml~(-1)范围内呈良好的线性关系(r=0.999 8)平均加样回收率为99.8%(RSD=0.83%,n=9),检测限和定量限分别为60 ng和300 ng。结论:该方法简便、准确,灵敏度高,重复性好,可用于盐酸阿普林定片的质量控制。
Objective: To establish a method for the simultaneous determination of aplidine hydrochloride tablets and related substances by high performance liquid chromatography. METHODS: The chromatographic column was Waters symmetry-C 18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol-0.02 mol·L -1 potassium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid) ( 50:50, v / v) at a flow rate of 1.0 ml · min -1. The detection wavelength was 254 nm and the column temperature was 35 ℃. The injection volume was 20 μl. Results: The linear range of apulin’s hydrochloride was 3.0 ~ 22.5μg · ml ~ (-1) (r = 0.999 8). The average recovery was 99.8% (RSD = 0.83%, n = 9 ), The limits of detection and limit of quantification were 60 ng and 300 ng, respectively. Conclusion: The method is simple, accurate, sensitive and reproducible. It can be used for the quality control of Aplidine hydrochloride tablets.