HPLC梯度洗脱法对盐酸曲唑酮片的杂质检查  

Related Impurities Determination of Trazodone Hydrochloride Tablets by HPLC

作　　者：万红艳 WAN Hong-yan(Fujian Provincial Institute for Drug Control,Fuzhou 350001,China)

机构地区：[1]福建省食品药品质量检验研究院化学药检验所,福建福州350001

出　　处：《海峡药学》2021年第10期60-62,共3页Strait Pharmaceutical Journal

摘　　要：目的建立HPLC梯度洗脱法检查盐酸曲唑酮片的杂质。方法采用Agilent Eclipse XDB-C_(18)色谱柱(4.6×250 mm,5μm);流动相A为乙腈,流动相B为二乙胺-水(0.4∶650),梯度洗脱;流速为2.0 mL·min^(-1);检测波长254 nm;柱温40℃。结果盐酸曲唑酮各杂质(杂质C、杂质D、杂质E)色谱峰与曲唑酮峰分离度良好,本法精密度、重复性、稳定性、耐用性好。结论可用于盐酸曲唑酮片的杂质检查。OBJECTIVE To establish a reversed phase high performance liquid chromatography(HPLC)gradient elution method for determination of the related substances in trazodone hydrochloride tablets.METHODS The method was carried out on an Agilent Eclipse XDB-C_(18) column(4.6×250 mm,5μm)with a mobile phase:diethylamine-water(0.4∶650)acetonitrile,gradient elution.The flow rate was 2.0 mL·min^(-1) and the detective wavelength was 254 nm.The temperature of column was 40℃.RESULTS The separation of the chromatographic peaks of impurities(impurity C,impurity D,impurity E)and trazodone is good.The method had excelent precision,repeatability,stability and durability.CONCLUSION This method can be used to determine impurities of trazodone hydrochloride tablets.

关 键 词：盐酸曲唑酮片 HPLC 梯度洗脱 杂质检查 

分 类 号：R969.4[医药卫生—药理学]