CAJ | 학술논문

目的：建立有效的HPLC方法测定注射用泮托拉唑钠中乙二胺四乙酸二钠的含量，并且对市场上一些企业的该品种进行了测定。方法色谱柱：Ultimate AQ-C18柱（4.6mm ×250mm，5μm）；流动相：0.5％磷酸二氢铵（用磷酸调pH至3.0）（A）～乙腈（B），梯度洗脱（0～10min，B 0％；10～15min，B 0％→50％；5～20min，B 50％；20～20.10min，B 50％→0％；20.10～30min，B 0％）；流速：1.0mL· min －1；检测波长：254nm；进样量：20μL；柱温：40℃。结果线性回归方程为Y＝9981.2X－2179.8，r＝0.9999，乙二胺四乙酸二钠在4.59～68.85mg· L－1范围内线性关系良好；精密度为RSD 0.6％；平均回收率为98.17％（n＝9），RSD 0.53％，样品在12h内基本稳定。结论此方法快速，准确，灵敏度高。可用于测定注射用泮托拉唑钠中的乙二胺四乙酸二钠含量。
목적：건립유효적HPLC방법측정주사용반탁랍서납중을이알사을산이납적함량，병차대시장상일사기업적해품충진행료측정。방법색보주：Ultimate AQ-C18주（4.6mm ×250mm，5μm）；류동상：0.5％린산이경안（용린산조pH지3.0）（A）～을정（B），제도세탈（0～10min，B 0％；10～15min，B 0％→50％；5～20min，B 50％；20～20.10min，B 50％→0％；20.10～30min，B 0％）；류속：1.0mL· min －1；검측파장：254nm；진양량：20μL；주온：40℃。결과선성회귀방정위Y＝9981.2X－2179.8，r＝0.9999，을이알사을산이납재4.59～68.85mg· L－1범위내선성관계량호；정밀도위RSD 0.6％；평균회수솔위98.17％（n＝9），RSD 0.53％，양품재12h내기본은정。결론차방법쾌속，준학，령민도고。가용우측정주사용반탁랍서납중적을이알사을산이납함량。
ABSTRACT:OBJECTIVE To establish a efficient method to determine the contents of disodium edetate in panto-prazole sodium for injection.And to choose pantoprazole of some manufactures , determine the contents of disodium edetate.METHODS The chromatographic column was Ultimate AQ-C18 (4.6mm ×250mm,5μm);the mobile phase:0.5%ammonium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid)(A)-acetonitrile(B),gra-dient elution(0~10min,0%B;10~15min,0%B→50%B;15~20min,50%B;20~20.10min,50%B→0%B;20.10~30min,0%B);the flow rate was 1.0mL· min -1;the detection wavelength was 254nm;the amount of inject was 20μL;the column temperature was 40℃.RESULTS The linear regression equation was Y =9981.2 X -2179.8 ( r=0.9999 ).The calibration curve of disodium edetate was linear in the range of 4.59~68.85 mg · L-1 with the RSD was 0.6%;the total recovery was 98.17%( n =9,RSD =0.53%);The samples were stable in 12 hours.CONCLUSION The method is rapid ,accurate and reliable for content determination of disodium edetate in pantoprazole.The retention time could be used to preliminary judgment of the exsistence of disodium edetate.