摘要
目的:建立测定苯甲酸阿格列汀片含量的方法。方法:采用高效液相色谱法。色谱柱为Kromasil C18,流动相为0.05 mol/L的KH2PO4溶液(pH3.0)-乙腈(65∶35),流速为1.0 ml/min,紫外检测波长为224 nm,进样量为20μl。结果:苯甲酸阿格列汀检测质量浓度线性范围为19.96~179.6μg/m(lr=0.999 9);平均回收率为99.54%(RSD=0.51%,n=9)。结论:本方法操作简便、快捷,结果准确、可靠,可用于苯甲酸阿格列汀片的质量控制。
OBJECTIVE： To establish a method for the content determination of Alogliptin benzoate tablets. METHODS： HPLC method was adopted. The determination was separated on Kromasil C^8 column with mobile phase consisted of 0.05 mol/L KH2PO4 （pH3.0）-acetonitrile （65：35） at flow rate of 1.0 ml/min. The detection wavelength was 224 nm and sample size was 20 pl. RESULTS： The linear range of alogliptin benzoate was 19.96-179.6 μg/ml （r=0.999 9） with an average recovery of 99.54% （RSD=0.51%, n=9）. CONCLUSIONS： This method is simple, rapid, accurate and reliable, and it is applicable for the quality control of Alogliptin benzoate tablets.
出处
《中国药房》
CAS
CSCD
2013年第37期3521-3522,共2页
China Pharmacy
