CAJ | 학술논문

目的：采用反相HPLC法测定依折麦布片的有关物质及含量。方法采用HPLC法，色谱柱为Hypersil BDS （150mm×4.6mm，5μm）；流动相为0.05mol/L磷酸二氢钾溶液-乙腈-四氢呋喃（65：25：10）等度洗脱；流速为1.0mL?min-1；柱温为30℃；检测波长为232nm。结果所采用的分析方法，能较好的分离依折麦布片的有关物质，其线性范围是98.6～295.9μg/ml（r=0.9999），最低检测限0.9ng，平均回收率为100.3%，方法精密度RSD=0.72%（n=9）。结论该方法操作简单，灵敏度高，准确可靠，可用于测定依折麦布片的含量及有关物质。
목적：채용반상HPLC법측정의절맥포편적유관물질급함량。방법채용HPLC법，색보주위Hypersil BDS （150mm×4.6mm，5μm）；류동상위0.05mol/L린산이경갑용액-을정-사경부남（65：25：10）등도세탈；류속위1.0mL?min-1；주온위30℃；검측파장위232nm。결과소채용적분석방법，능교호적분리의절맥포편적유관물질，기선성범위시98.6～295.9μg/ml（r=0.9999），최저검측한0.9ng，평균회수솔위100.3%，방법정밀도RSD=0.72%（n=9）。결론해방법조작간단，령민도고，준학가고，가용우측정의절맥포편적함량급유관물질。
Objective To establish an RE-HPLC method for the determination of ezetimibe and its related substances in ezetimibe tablets. Methods The analysis was performed on a Cl8 column(150mm×4.6mm, 5μm). The mobile phase consisted of potassium dihydrogen phosphate 0.05mol/L:acetonitrile:tetrahydrof uran=65∶25∶10. The flow rate was 1.0mL?min-1 and the column temperature maintained at 30℃. The detective wavelength was 232 nm. Results Ezetimibe and its related substances were well-separated by this method, and the linear range of ezetimibe was 98.6~295.9μg/ml, r=0.9999. The average recovery of ezetimibe was 100.3% with the RSD was 0.72% (n=9). Conclusion This method is simple, sensitive and accurate,which can be used for the quality control in ezetimbie tablets.