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HPLC法测定盐酸三氟拉嗪含量及有关物质
引用本文:张君,廖声华,严拯宇.HPLC法测定盐酸三氟拉嗪含量及有关物质[J].海峡药学,2010,22(3):43-45.
作者姓名:张君  廖声华  严拯宇
作者单位:中国药科大学分析化学教研室,南京,211198
摘    要:目的建立盐酸三氟拉嗪含量测定及有关物质限量检查的HPLC法。方法采用C18柱,以乙腈-磷酸盐缓冲溶液(0.05mol·L^-1NaH2PO4.2H2O100mL,加2mL的三乙胺后用磷酸调节pH至3.0)(38∶62)为流动相。流速:1.0mL·min^-1,柱温:30℃,检测波长:258nm。结果盐酸三氟拉嗪与其他杂质能较好分离,盐酸三氟拉嗪浓度在2.5~25μg·m^L-1范围内线性关系良好(r=0.9997),检测限为0.016μg·mL^-1。结论本方法灵敏、准确、专属性好,可用于盐酸三氟拉嗪的含量测定及有关物质限量检查。

关 键 词:盐酸三氟拉嗪  高效液相色谱法  含量测定  有关物质

Determination of trifluoperazine hydrochloride and its related substances by HPLC
ZHANG Jun,LIAO Sheng-hua,YAN Zheng-yu.Determination of trifluoperazine hydrochloride and its related substances by HPLC[J].Strait Pharmaceutical Journal,2010,22(3):43-45.
Authors:ZHANG Jun  LIAO Sheng-hua  YAN Zheng-yu
Institution:(China Pharmaceutical University,Nanjing 211198,China)
Abstract:OBJECTIVE To establish HPLC methods for the determination of trifiuoperazine hydrochloride and its related substances.Methods C18 column was used,the mobile phase wasacetonitrile-phosphate buffered solution(0.05 mol·L^-1 NaH2PO4·2H2O 100mL,add 2 mLtriethylamine,and adjusted to pH 3.0 with phosphoric acid)(38∶62).The flow rate was 1.0ml·min^-1,the column temperature was 30℃ and the detection wavelength of UV detector was258 nm.RESULTS trifluoperazine hydrochloride was separated completely from impurities.Thelinear range of trifluoperazine hydrochloride was 2.5~25μg·mL^-1(r=0.9997).The limit of quantitation was 0.016ug·mL^-1.CONCLUSION With good sensitivity,accuracy,and selectivity,the method can be applicable for the determination of trifiuoperazine hydrochloride and its related substances.
Keywords:trifiuoperazine hydrochloride  HPLC  quantification  related substances
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