CAJ | 학술논문

目的建立并验证脑膜炎球菌结合物原液中残余二甲亚砜的检测方法。方法采用液相色谱法，使用Kro-masil C18柱（250 mm×4．6 mm），25％甲醇溶液为流动相，二极管阵列检测器测定脑膜炎球菌结合物原液中残余二甲亚砜。结果二甲亚砜在1～100 mg/L的范围内相关系数r大于0．999，线性关系良好，平均回收率为94％～114％、变异系数为0．46％～0．89％，最小定量限为1．0 mg/L，远低于药典规定。结论该方法简便易行，结果准确。
목적건립병험증뇌막염구균결합물원액중잔여이갑아풍적검측방법。방법채용액상색보법，사용Kro-masil C18주（250 mm×4．6 mm），25％갑순용액위류동상，이겁관진렬검측기측정뇌막염구균결합물원액중잔여이갑아풍。결과이갑아풍재1～100 mg/L적범위내상관계수r대우0．999，선성관계량호，평균회수솔위94％～114％、변이계수위0．46％～0．89％，최소정량한위1．0 mg/L，원저우약전규정。결론해방법간편역행，결과준학。
Objective To establish a method for determination of the residual dimethylsulfoxide ( DMSO) in meningococcal conjugates bulk of A , C, Y and W135.Methods HPLC was used in this test .The content of DMSO was analyzed with Kromasil C18 column (250 mm×4.6 mm), the mobile phase was 25% methanol, and diode array detector was used as detector.Results A good liner correlation was obtained over the range of 1-100 mg/L, r>0.999.The average recovery of DMSO was 94%-114%and the average CV was 0.46%-0.89%.The method can quantify the DMSO with a minimum amount of 1.0 mg/L for the sensitivity at least 10 times higher than that of noise assay .This concentration was much lower than the limit concentration in p harmacopeia .Conclusions This method was easily operative and accurate for precise determination.