CAJ | 학술논문

目的测定氯尼达明的有关物质和含量.方法在系统适用性和专属性试验的基础上,采用反相色谱柱[Hypersil C18硅烷柱(ODS)(200×4.6 mm)]:流动相为甲醇-水-冰醋酸(80:11:1);柱温为:25℃;流速为1.0 ml/min;检测波长为298 nm,建立测定氯尼达明有关物质和含量的高效液相色谱法.结果氯尼达明在2～16μg/ml 浓度范围内与其峰面积呈线性关系,回归方程为A=7043C-108353,r=0.9914,测得的氯尼达明含量在98.5%以上,有关物质含量均小于1%.结论高效液相色谱法测定氯尼达明的有关物质和含量方法准确、简便、可行,重现性和稳定性好,可适用于氯尼达明的含量测定及其有关物质检测.
목적 측정록니체명적유관물질화함량.방법 재계통괄용성화전속성시험적기출상,채용반상색보주[Hypersil C18규완주(ODS)(200×4.6 mm)]:류동상위갑순-수-빙작산(80:11:1);주온위:25℃;류속위1.0 ml/min;검측파장위298 nm,건립측정록니체명유관물질화함량적고효액상색보법.결과 록니체명재2～16μg/ml 농도범위내여기봉면적정선성관계,회귀방정위A=7043C-108353,r=0.9914,측득적록니체명함량재98.5%이상,유관물질함량균소우1%.결론 고효액상색보법측정록니체명적유관물질화함량방법준학、간편、가행,중현성화은정성호,가괄용우록니체명적함량측정급기유관물질검측.
Objective To observe the impurities and assay of Lonidamine.Methods Based on the system suitability and specificity, a reversed-phase column [Hypersil C18 column silane (ODS) (200 × 4.6 mm)] and a methanol-water-glacial acetic acid (80: 11:1) mobile phase, Lonidamine's related substances and content were determined by HPLC with the column temperature 25℃, the flow rate 1.0 ml/min and the detection wave length 298 nm.Results Lonidamine is linear relationship with its peak area in in the concentration range of 2 ～ 16 μg/ml,its regression equation is A = 7043C-108353, r = 0.9914. All the contents were above 98.5%. Conclusion Determination of lonidamine related material and content by high performance liquid is accurate, simple, feasible,as well as of high reproducibility and stability.