HPLC法测定盐酸曲普利啶中顺式异构体及其他杂质含量  

HPLC Determination of Triprolidine Hydrochloride Z-Isomer and Other Impurities in Triprolidine Hydrochloride

作　　者：陈华 钟雅妮 刘俊华 李小婵 

机构地区：[1]珠海联邦制药股份有限公司,广东中山528467

出　　处：《今日药学》2013年第7期424-426,435,共4页Pharmacy Today

摘　　要：目的建立HPLC法测定盐酸曲普利啶中顺式异构体及其他杂质含量的方法。方法采用Inertsil ODS-3(4.6 mm×250 mm,5μm)为色谱柱;以甲醇-醋酸铵溶液(取0.4%的醋酸铵溶液300 mL,加1 mL三乙胺,用冰醋酸调节pH值至5.5)(65∶35)为流动相;检测波长为254 nm。结果盐酸曲普利啶顺式异构体线性范围为0.000 1～0.039 0 mg/mL(r=0.999 9),定量限和检测限分别为4、0.8 ng,回收率为99.5%(n=9);测定结果重复性良好,盐酸曲普利啶顺式异构体、其他单个杂质、总杂的RSD(n=6)分别为1.95%、3.60%、1.92%。结论该方法灵敏、准确,专属性好,可用于测定盐酸曲普利啶中顺式异构体及其他杂质的含量。Objective To establish an HPLC method for the determination of Triprolidine Hydrochloride Z-Isomer and other impurities in Triprolidine Hydrochloride. Methods The separation was performed on Inertsil ODS-3 （4.6 mm× 250 mm, 5 μm） column; The mobile phase was composed of methanol and ammonium acetate solution （concentration of 0.4% ammonium acetate solution 300 mL, add 1 mL three ethylamine and adjust pH value to 5.5 with glacial acetic acid） （65：35 ） ;The detection wavelength was 254 nm. Results The linearity of Triprolidine Hydrochloride Z-Isomer was 0. 000 1 - 0. 039 0 mg/mL （ r = 0. 999 9 ）, and its quantization and detection limits were 4 ng and 0. 8 ng, respectively, the recovery was 99.5 % （ n = 9） ; The results showed good repeatability, the RSD （ n = 6） of Hydrochloride Z-Isomer, the other impuritie and total impurities were 1.95%, 3.60%, 1.92%, respectively. Conclusion The method is sensitive, accurate, specificity, and it can be used for determination of Triprolidine Hydrochloride Z-Isomer and other impurities in Triprolidine Hydrochloride.

关 键 词：盐酸曲普利啶 盐酸曲普利啶顺式异构体 杂质 高效液相色谱法 

分 类 号：R927[医药卫生—药学]