摘要
目的建立那格列奈含量及有关物质的HPLC测定方法。方法以C18柱，磷酸盐缓冲液（pH3．0）-乙（50：50）为流动相，流量为1．0ml·min^-1，柱温30℃，检测波长为210nm。结果在浓度为0．0601-1．8030μg范围线形关系良好，相关系数r=0．9993（n=6），重复性试验的RSD为0．9％（n=6）。有关物质分离较好。结论本方法简单、准确，可作为那格列奈含量和有关物质的测定方法。
AIM To develop a HPLC method for the determination of nateglinide and its related substances. METHODS The determination was carried out on a C18 column. The mobile phase was consisted of phosphate buffer solution （pH 3.0 ） -acetonitrile （50：50） with flow rate of 1.0 ml·min^-1 and the column temperature was 30 ℃. The detection wave-length was 210 nm. RESULT There was a good linearity over the range of 0.0601 - 1.8030 μg with a correlation coefficient r = 0.9993, （ n = 6）. The RSD for repetition was 0.9% （ n = 6）. CONCLUSION The method was simple and accurate,it can be used as a method for the quality control.
出处
《江苏药学与临床研究》
2006年第4期238-240,共3页
Jiangsu Pharmacertical and Clinical Research
