高效液相色谱法测定盐酸左西替利嗪颗粒中的有关物质  

Determination of Related Substances of Levocetirizine Dihydrochloride Granules by HPLC

作　　者：洪江游 洪志慧[2] 凌日金 谢清春[3] 

机构地区：[1]海南康芝药业股份有限公司,海南海口570311 [2]深圳市红会医院,广东深圳518000 [3]广东药学院,广东广州510006

出　　处：《中国医药指南》2012年第18期75-77,共3页Guide of China Medicine

摘　　要：目的建立盐酸左西替利嗪颗粒中对映异构体盐酸右西替利嗪和其他有关物质的检测方法。方法采用Ultron ES-OVM卵黏蛋白手性色谱柱(50×4.6mm,5μm),以0.02mol/L磷酸氢二钾溶液-乙腈(86∶14,pH值6.6)为流动相,检测波长230nm,检测本品中对映异构体盐酸右西替利嗪;采用Apollo C18柱(250×4.6mm,5μm),以0.02mol/L磷酸二氢钠溶液-甲醇以(30∶70)为流动相,检测波长为230nm,检测本品其他相关物质。结果盐酸右替利嗪可以盐酸左替利嗪分离度符合求,其他有关物质测定相关分离也满足检测要求。结论本文的检测方法可以用于本品中有关物质的测定。Objective To establish HPLC Methods to determine related substance of Levocetirizine dihydrochloride granules. Method To determine dextrocetirizine of Levocetifizine, Ultron ES-OVM Column was used, 0.02mol/L solution of dipotassium hydrogen phosphate -Acetonitrile （86 ： 14, pH at 6.6） as mobile-phase, detection wavelength at 230nm; To determine other related substance, Apollo C 18 column was used, 0.02mol/L solution of dipotassium hydrogen phosphate - Methanol （30 ： 70） as mobile-phase, detection wavelength at 230nm. Levocetirizine dihydrochloride was exposed to various stress conditions such as acid, base, oxidation ＆ thermal degradations along with Placebo ＆ Formulation. Result Resolution of levocetirizine and rivocetirizine met the analysis requirements, and other related substance also met the analysis requirements. Conclusion The assay method can be used to determine the related substance of levoeetirizine dihydrochloride granules.

关 键 词：盐酸左西替利嗪 有关物质 高效液相 

分 类 号：R965[医药卫生—药理学]