HPLC衍生化法测定克林霉素磷酸酯注射液中依地酸二钠  

Determination of disodium edetate in clindamycin phosphate injection by HPLC derivatization

作　　者：陈希 肖钦钦 饶艳春 CHEN Xi;XIAO Qin-qin;RAO Yan-chun(Jiangxi Institute for Drug Control,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《化学工程师》2025年第2期30-33,共4页Chemical Engineer

摘　　要：目的建立克林霉素磷酸酯注射液中依地酸二钠的测定方法。方法采用HPLC法,以CuSO4为衍生剂,流动相A:0.01mol·L^(-1)KH2PO4溶液(pH值为2.2),流动相B:甲醇,梯度洗脱,色谱柱:Welch Ulitmate OAA(4.6×300mm),流速:1.0mL·min-1,检测波长:240nm,进样量:20μL。结果依地酸二钠在2~100μg·mL^(-1)浓度范围内线性关系良好,回收率为97.90%~101.58%,平均为99.4%(RSD=1.3%,n=9)。结论本方法前处理简单方便,具有较好的准确度、灵敏度和精密度,适用于克林霉素磷酸酯注射液中依地酸二钠的质量控制。OBJECTIVE To establish a method for the determination of disodium edetate in clindamycin phosphate injection.METHODS HPLC was used with copper sulfate as derivative,mobile phase A:0.01mol·L^(-1)potassium dihydrogen phosphate solution(pH=2.2),mobile phase B:methanol,gradient elute,column:Welch Ulitmate OAA column(4.6×300mm),flow rate:1.0mL·min-1,detection wavelength:240nm,injection valume:20μL.RESULTS Disodium edetate had a good linear relationship in the range of 2~100μg·mL^(-1),and the recoveries were 97.90%~101.58%with an average of 99.4%(RSD=1.3%,n=9).CONCLUSION The pretreatment method is simple and convenient.The method has good accuracy,sensitivity and precision,and is suitable for the quality control of disodium edetate in clindamycin phosphate injection.

关 键 词：克林霉素磷酸酯注射液 HPLC 衍生化 依地酸二钠 

分 类 号：R917[医药卫生—药物分析学]