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
王璐 1杜启璐 1曹桂红1
作者信息
- 1. 贵州省食品药品检验所,贵州 贵阳 550004
- 折叠
摘要
目的:采用Waters C18柱(5 μm,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 mL,用水稀释至1000 mL)-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 20.272～141.904 μg 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.
Abstract
Methods:The test was performed in WATERS C18 column(5 μm,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 20.272～141.904 μg 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Key words
Chlorphenamine Maleate/Compound indomethacin/HPLC引用本文复制引用
出版年
2024
NETL
NSTL
万方数据