摘要
目的:建立盐酸依匹斯汀胶囊含量和有关物质的HPLC测定方法。方法:采用ZORBAX SB-CN柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.05 mol.L-1磷酸盐缓冲溶液(取磷酸二氢钠6.8 g,溶解于1000 mL水中,精密加三乙胺3 mL,摇匀,用磷酸调pH至4.5±0.1)(35∶65);流速为1.0 mL.min-1;检测波长为220 nm;柱温为30℃。结果:在该选定色谱条件下,主峰与有关物质峰分离度良好,盐酸依匹斯汀在147.0～239.4μg.mL-1浓度范围内线性关系良好(r=0.9999);平均回收率为100.8%(n=9);检测限为0.5 ng。结论:该方法专属、灵敏、简便,可用于测定盐酸依匹斯汀胶囊的含量及有关物质。
Objective：To establish an HPLC method for determination of epinastine hydrochloride capsules and its related substances.Methods：The separation was performed on a ZORBAX SB-CN（250 mm×4.6 mm,5 μm） column with the mobile phase consisting of acetonitrile-0.05 mol·L-1 phosphate solution（buffer solution：6.8 g of sodium dihydrogen phosphate was dissolved in 1000 mL water,3 mL of triethylamine was added exactly,the mixture was shaked and adjusted to pH 4.5±0.1 with phosphate acid）（35∶ 65） at the flow rate of 1.0 mL·min-1.The detection wavelength was set at 220 nm The column temperature was 30 ℃.Results：Under the above conditions,the main peak and the peaks of the related stabstances were separated quite well.Epinastine hydrochloride capsules had a good linear relationship（r=0.9999） within the range of 147.0-239.4 μg·mL-1.The average recovery（n=9） was 100.8%.The limit of the detection was 0.5 ng.Conclusion：The method is sensitive,specific and simple.It can be used for determining epinastine hydrochloride capsules and its related substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第8期1409-1413,共5页
Chinese Journal of Pharmaceutical Analysis
