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.mL-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。
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.
出处
《海峡药学》
2010年第3期43-45,共3页
Strait Pharmaceutical Journal
