HPLC法测定盐酸左旋去甲基苯环壬酯片的含量及有关物质  

Determination of contents and related substances of demethyl levophencynonate hydrochloride tablets by HPLC

作　　者：孙建绪[1] 王晓青[2] 张晓燕[1] 李娇娇[1] 仲伯华[1] 郑建全[1] 何新华[1] 王丽韫[1] 郑爱萍[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]解放军总医院第一附属医院药剂科,北京100037

出　　处：《军事医学》2014年第10期811-813,共3页Military Medical Sciences

基　　金：国家科技重大专项资助项目(2009ZX09102-038)

摘　　要：目的：建立盐酸左旋去甲基苯环壬酯（ demethyl levophencynonate hydrochloride，L-LPC）片的含量及有关物质的分析方法。方法采用高效液相色谱法；色谱柱Capcel PAK C18柱， MGⅡ5μm，4．6 mm ×250 mm，Col：No．A4AD 02992（Shiseido，日本）；流动相甲醇∶乙腈∶0．05 mol/L醋酸钠缓冲溶液（pH 5．0）为4∶3∶3；流速1．0 ml/min；检测波长220 nm；进样量20μl；柱温为室温。结果方法回收率为（100．15±0．73）％；溶液在8 h保持稳定（RSD为0．36％）；在0．1～50μg/ml范围内线性关系良好，其回归方程为Y＝81558X-4768．3（R2＝1，n＝3）。结论所建立的方法简便、准确、灵敏，专属性强，为该制剂含量测定、半成品测定及制剂稳定性研究提供了方法学依据。Objective To establish a simple, feasible and precise quality control method for the determination of contents and related substances of demethyl levophencynonate hydrochloride （L-LPC）tablets.Methods The mobile phase consisted of methanol,acetonitrile and sodium acetate buffer solution（pH 5.0）,at a ratio of 4∶3∶3,at a flow rate 1.0 ml/min and a detection wavelength of 220 nm.Samples were injected 100 μl and determined at room temperature.Results The calibration curves showed good linearity （R2 =1） within the test range of 0.1-50μg/ml.The recovery of the method was about （100.15 ±0.73）%, and the stability of working solutions was acceptable in 8 h （RSD=0.36%）.Conclusion The results indicated that the developed method can be readily used as a quality control method.

关 键 词：盐酸左旋去甲基苯环壬酯片 高效液相色谱法 含量 有关物质 

分 类 号：R927[医药卫生—药学] O657.72[理学—分析化学]