HPLC法测定盐酸左旋咪唑片的含量及溶出度  

Determination of the content and sissolution of Levamisole hydrochloride tablets by HPLC

作　　者：曾建亭 钟小燕 

机构地区：[1]清远市药品检验所,广东清远511500 [2]清远市慢性病防治医院,广东清远511515

出　　处：《中国热带医学》2010年第5期628-629,共2页China Tropical Medicine

摘　　要：目的建立用高效液相色谱法测定盐酸左旋咪唑片的含量及溶出度的方法。方法采用反相高效液相色谱法,以Diamonsil C18柱(250mm×4.6mm,粒直径5μm)为固定相;0.05mol/L磷酸二氢钾-乙腈(80:20)为流动相;流速为1.0ml/min;检测波长为214nm;柱温:25℃。结果盐酸左旋咪唑在1～50μg/m(lr=0.9999)范围内呈良好的线性关系,平均回收率为99.6%(n=6),溶出量30min内大于标示量的80%。结论所建立的方法准确、可靠、重现性好,适用于盐酸左旋咪唑片的质量控制。Aim To establish a HPLC method for determination of content of levamisole hydrochloride tablets. Methods Reversed phase high performance liquid chromatography（RP-HPLC） was used. The chromatographic conditions included Diamonsil C18 column（250mm×4.6mm,5μm）,0.05mol/L potassium dihydrogen phosphate-acetonitrile （80：20） as the mobile phase with flow rate of 1.0mL/min ,wavelength of detector was at 214 nm;The column temperature was 25℃. Results The calibration curve of levamisole hydrochloride was linear over the range of 1-50μg/ml（r=0.9999）.and the average recovery rate was 99.6%（n=6）, the dissolved volume was more than 80% in 30min. Conclusion This method is accurate, reliable and can be used for quality control of levamisole hydroehloride tablets.

关 键 词：盐酸左旋咪唑片 高效液相色谱法 溶出度 含量测定 

分 类 号：R978.63[医药卫生—药品]