高效液相色谱法测定复方吲哚美辛酊中马来酸氯苯那敏的含量  

Determination of Chlorphenamine Maleate in Compound Indomethacin Tincture by HPLC

作　　者：王璐 杜启璐 曹桂红[1] Wang Lu;Du Qiu;Cao Guihong(Guizhou Institute for Food and Drug Control,Guiyang 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《广东化工》2024年第11期142-143,150,共3页Guangdong Chemical Industry

基　　金：2015年国家药品标准提高项目(271)。

摘　　要：目的:采用Waters C18柱(5μm,4.6*250 mm),以磷酸盐缓冲液(取磷酸二氢铵11.5 g,加适量水使其溶解,加磷酸1 m L,用水稀释至1000 m L)-乙腈(80∶20)为流动相。流速1.0 mL/min,检测波长为262,柱温为30℃条件下,建立高效液相色谱(HPLC)测定马来酸氯苯那敏的方法。结果表明,马来酸氯苯那敏的进样量在20.272~141.904μg范围内有良好的线性关系,回归方程y=0.1153x-0.0162(R=0.9999),方法回收率为99.19%~101.68%之间,RSD为0.9%。6批样品的马来酸氯苯那敏含量在98.97%~101.58%之间;结论:此方法专属性强,精密度稳定性良好,准确度较高,可用于该制剂中马来酸氯苯那敏的含量测定。Methods:The test was performed in WATERS C18 column(5μm,4.6*250 mm)with acetonitrile and phosphate buffer solution(ammonium dihydrogen phosphate 11.5 g,dissolved in appropriate amount of water,added phosphoric acid 1 mL,diluted to 1000 mL by adding water)as mobile phase(80∶20).The flow rate was 1.0 mL/min,the detection wavelength was 262 nm,and the column temperature was 30℃.To establish the method for determination of Chlorphenamine Maleate in Compound indomethacin tincture by HPLC.Results:The linear range fell into 20.272~141.904μg the calibration equation was y=0.1153x-0.0162(R=0.9999),and the average recovery was between 99.19%~101.68%with RSD as 0.9%for chlorphenamine maleate.The contents of Chlorphenamine Maleate 6 batches samples was between 98.97%~101.58%.Conclusion:This estabilished method is reliable and accurate.It can be used for determination of chlorphenamine maleate in Compound indomethacin.

关 键 词：复方吲哚美辛酊 马来酸氯苯那敏 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]