双氯芬酸钾软胶囊有关物质检测  

Detection of Related Substances in Diclofenac Potassium Soft Capsules

作　　者：夏平 邹春阳 孟祥军[2] XIA Ping1, ZOU Chun-yang1, MENG Xiang-jun2(1. Liaoning Medicine Vocational College, Liaoning Shengyang 110101, China; 2. Medical Center of Shenyang Medical College, Liaoning Shenyang 110034, China)

机构地区：[1]辽宁医药职业学院,辽宁沈阳110101 [2]沈阳医学院药物中心,辽宁沈阳110034

出　　处：《辽宁化工》2018年第3期204-206,共3页Liaoning Chemical Industry

摘　　要：建立了双氯芬酸钾软胶囊中有关物质的检测方法。通过高效液相色谱法对样品中有关物质的检测,以控制产品质量。按照高效液相色谱法测定,用十八烷基硅烷键合硅胶为填充剂,以甲醇-水-冰醋酸(80∶20∶0.8)为流动相,检测波长为257 nm,流速为1.0 mL·min^(-1),柱温为室温,进样量为20μL。采用杂质峰面积对照法对双氯芬酸钾软胶囊有关物质进行检测。结果表明,系统适用性实验中,理论塔板数按双氯芬酸钾峰计算应不低于2 000,杂质A峰与双氯芬酸钾峰之间分离度至少为6.5。单个杂质峰面积不得大于对照溶液主峰面积(0.2%);各杂质峰面积的和不得大于对照溶液主峰面积的2.5倍(0.5%)。此方法专属性强,耐用性好,灵敏度高,可用于质量控制。本品有关物质检测结果符合双氯芬酸钾标准中有关物质的限度要求,且可以有效控制产品质量。A determination method of related substances in diclofenac potassium soft capsule was established. Detecting the related substances by high performance liquid chromatography can control the quality of products. During the determination with high performance liquid chromatography, octadecylsilane bonded silica was used as a filler,methanol-water-glacial acetic acid solution（80：20：0.8）was used as mobile phase. The detection wavelength was 257 nm, the flow rate was 1.0 mL·min（-1）,the column temperature was room temperature, the injection volume was 20 μL. Related substances in the diclofenac potassium soft capsules were detected by the method of impurity peak area. The results showed that,the number of theoretical plates was not less than 2000,separating degree was not less than 6.5 for each impurity, the peak area of single impurity was not more than the area of the principal peak（0.2%）,the total area of the impurity peak was not more than 2.5 times the area of the principal peak（0.5%）. This method has high specificity, good precision, high sensitivity, and can be used for quality control. This product related substances test results meet the requirements of the limit of related substances in diclofenac potassium standard.

关 键 词：双氯芬酸钾软胶囊 有关物质 高效液相色谱法 

分 类 号：O657.7[理学—分析化学]