【摘要】：目的:建立同時(shí)測(cè)定鹽酸阿普林定片含量及有關(guān)物質(zhì)的方法。方法:采用反相高效液相色譜法。色譜柱為Dikma Diamonsil C18,流動(dòng)相為甲醇-水-10%四丁基氫氧化銨溶液(40∶60∶2,V/V/V,用磷酸調(diào)節(jié)p H至3.0),流速為1.0 ml/min,檢測(cè)波長為258 nm,柱溫為30℃,進(jìn)樣量為10μl。結(jié)果:鹽酸阿普林定質(zhì)量濃度在25.55~204.40μg/ml范圍內(nèi)與其峰面積呈良好的線性關(guān)系(r=0.999 4);精密度、穩(wěn)定性、重復(fù)性試驗(yàn)的RSD≤0.6%;平均回收率為100.1%,RSD=0.5%(n=9);雜質(zhì)總量≤0.84%。結(jié)論:本方法簡便、準(zhǔn)確、專屬性好、靈敏度高,可用于鹽酸阿普林定片的質(zhì)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，

本文編號(hào)：2459391