反相高效液相色谱法测定双苯氟嗪及其片剂的含量和有关物质  

RP-HPLC determination of content and related substances of dipfluzine and its tablets

作　　者：陈汝红[1] 郭毅[1] 刘铁钢[1] 王永利[2] 张兰桐[2] 

机构地区：[1]河北省药品检验所,石家庄050011 [2]河北医科大学药学院,石家庄050017

出　　处：《药物分析杂志》2006年第4期486-490,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立 HPLC 法测定双苯氟嗪及其片剂的含量和有关物质。方法:采用 C_(18)柱(200 mm×4.6 mm,5 μm),甲醇-乙腈-缓冲溶液(取四丁基溴化铵14.99 g,磷酸二氢钾3.16 g,用水溶解并稀释至1000 mL)(47:10:43,用磷酸调节 pH 为3.5)为流动相,流速1 mL·min^(-1),检测波长230 nm,柱温35℃。结果:双苯氟嗪在0.02～1 mg·mL^(-1)浓度范围内线性关系良好,r=0.9999;平均回收率为99.8%(n=9)。双苯氟嗪与相邻杂质峰完全分离,双苯氟嗪的检测限为1.2 ng,定量限为3.7 ng。结论:本法简便、专属、准确,可作为双苯氟嗪及其片剂含量和有关物质的测定方法。Objective：To establish an HPLC method for determination of content and related substances of dipfluzine and its tablets. Methods： The column ： C18 （200mm × 4.6 mm,5μm） ; The mobile phase： a mixture of methanol, acetonitrile and buffer solution （47 ： 10： 43, adjust to pH 3.5 with phosphonic acid） ; The flow rate ： 1 mL·min^-1 ; The detection wavelength ： 230 nm ; The column temperature ： 35℃. Results： The linear range of dipfluzine was 0. 02 - 1 mg· mL^-1, r = 0. 9999. The average recovery of dipfluzine was 99.8% （ n = 9 ） respectively. Dipfluzine could be completely separated from the other impurities. Limit of detection for dipfluzine was 1.2 ng. Limit of quantitation for dipfluzine was 3.7 ng. Conclusion： The proposed HPLC method is convenient, specific, accurate. The method can be used for determination of content and related substances of dipfluzine and its tablets.

关 键 词：双苯氟嗪 含量 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]