达格列净片含量及均匀度测定研究
KEXUE SHIDAI(2015)
Abstract
目的:建立高效液相色谱法测定达格列净片的含量及含量均匀度。方法:采用反相高效液相色谱法测定达格列净片的含量,色谱柱为Shimpack VP-ODS,流动相为1%冰醋酸溶液-乙腈(45∶55),检测波长为242 nm,流速为1.0 ml/min,柱温为30℃。结果:空白辅料无干扰,线性范围为60g/ml~140μg/ml,r=0.9999(n=5),回收率在99.1%~100.5%之间(RSD=0.39%,n=9);3批样品含量及均匀度良好。结论:建立的含量及含量均匀度测定方法准确可靠,可用于本品含量及均匀度的测定。
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