CAJ | 학술논문

目的：建立一种方法简便，结果可靠的正相高效液相色谱法用于注射用埃索美拉唑钠的对映异构体检测，解决反相高效液相色谱法检测时出现杂质干扰的不足。方法色谱柱为Chiralpak IC（4.6mm ×250mm，5μm），以正己烷∶无水乙醇＝60∶40为流动相，流速0.7mL· min 1，检测波长为302nm。结果在本方法中，埃索美拉唑的线性关系良好，r为0.9999；专属性强，埃索美拉唑与对映异构体之间的分离度良好，与干扰杂质能有效分离；精密度和稳定性良好，RSD均小于2％。结论该方法准确、简便、快速，可用于注射用埃索美拉唑钠的对映异构体测定。
목적：건립일충방법간편，결과가고적정상고효액상색보법용우주사용애색미랍서납적대영이구체검측，해결반상고효액상색보법검측시출현잡질간우적불족。방법색보주위Chiralpak IC（4.6mm ×250mm，5μm），이정기완∶무수을순＝60∶40위류동상，류속0.7mL· min 1，검측파장위302nm。결과재본방법중，애색미랍서적선성관계량호，r위0.9999；전속성강，애색미랍서여대영이구체지간적분리도량호，여간우잡질능유효분리；정밀도화은정성량호，RSD균소우2％。결론해방법준학、간편、쾌속，가용우주사용애색미랍서납적대영이구체측정。
OBJECTIVE To establish a simple、reliable normal phase HPLC method for the determination of en-antiomers of Esomeprazole Sodium for Injection ,for solving the problem of impurities interference when detected by RP-HPLC method.METHODS The determination was carried out on Chiralpak IC (4.6mm ×250mm,5μm),with Hexane-ethanol (60∶40 ) as the mobile phase at the flow rate of 0.7mL · min-1.The detection wavelength was 302nm.RESULTS The method showed good linearity with a correlation coefficient (r) of 0.9999;Specific,and good separations;the precision and stability were satisfactory with all RSDs below 2%.CONCLUSION This meth-od is accurate ,simple and fast for the enantiomers of someprazole Sodium for Injection.