高效液相色谱法测定马来酸替加色罗缓释微丸胶囊中主药的含量  

Determination of the content of tegaserod maleate in tegaserod maleate sustain release pellets capsule by RP-HPLC

作　　者：蔡怿 谢琼玉[2] 

机构地区：[1]广东省汕头市皮肤性病防治院,515041 [2]广东省汕头市药品检验所,515041

出　　处：《临床合理用药杂志》2012年第16期1-2,共2页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的建立以高效液相色谱法测定马来酸替加色罗缓释微丸胶囊中马来酸替加色罗含量的方法。方法以Kromasil C18(250.0mm×4.6mm,5μm)为色谱柱,流动相为乙腈-0.2%磷酸溶液=40:60,检测波长为315nm,流速为1ml/min,柱温为30℃,进样量是20μl。结果马来酸替加色罗在32.8～328.4μg/ml范围内进样量与峰面积呈良好的线性关系(r=0.9997),平均回收率为99.91%,RSD=0.9%。结论本方法简便、准确、专属性强,可用于该制剂的含量测定。Objective To establish a method for the determination of tegaserod maleate in tegaserod maleate sustain release pellets capsule.Methods HPLC was performed on a C18（250.0mm×4.6mm,5μm） column,used acetonitrile-0.2% phosphoric acid solution（40：60） as the mobile phase at a flow rate of 1ml/min.The detection wavelength was at 315nm.The column temperature was 30℃ and the sample size was 20μl.Results The linear range of tegaserod maleate was 32.8~328.4μg/ml（r= 0.9997）,the average recovery was 99.91%（RSD=0.9%）.Conclusion The method is simple,accurate,special and can be used for the quality control of tegaserod maleate sustain release pellets capsule.

关 键 词：马来酸替加色罗缓释微丸胶囊 高效液相色谱法 含量 

分 类 号：R927.2[医药卫生—药学]