RP-HPLC法同时测定盐酸阿普林定片的含量和有关物质

发布时间：2019-04-17 11:39

【摘要】：目的:建立同时测定盐酸阿普林定片含量及有关物质的方法。方法:采用反相高效液相色谱法。色谱柱为Dikma Diamonsil C18,流动相为甲醇-水-10%四丁基氢氧化铵溶液(40∶60∶2,V/V/V,用磷酸调节p H至3.0),流速为1.0 ml/min,检测波长为258 nm,柱温为30℃,进样量为10μl。结果:盐酸阿普林定质量浓度在25.55~204.40μg/ml范围内与其峰面积呈良好的线性关系(r=0.999 4);精密度、稳定性、重复性试验的RSD≤0.6%;平均回收率为100.1%,RSD=0.5%(n=9);杂质总量≤0.84%。结论:本方法简便、准确、专属性好、灵敏度高,可用于盐酸阿普林定片的质量控制。
[Abstract]:Objective: to establish a method for simultaneous determination of alpine hydrochloride tablets and its related substances. Methods: reversed-phase high performance liquid chromatography (RP-HPLC) was used. The column was Dikma Diamonsil C18, the mobile phase consisted of methanol-water-10% tetraammonium hydroxide solution (40 渭 60 m2, V, adjusted pH to 3.0 with phosphoric acid), the flow rate was 1.0 ml/min, and the detection wavelength was 258 nm,. The column temperature was 30 鈩，

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