HPLC法测定复方制剂布洛芬盐酸曲马多片中2个有效成分含量  

Determination the content of two effective components in compound preparation of ibuprofen and tramadol hydrochloride tablets by HPLC

作　　者：何连军[1] 张莉华 HE Lian-jun;ZHANG Li-hua(Hangzhou Vocational and Technical College,Hangzhou 310018,China;Hangzhou He-ze Pharmaceutical Technology Co.,Ltd,Hangzhou 310018,China)

机构地区：[1]杭州职业技术学院,杭州310018 [2]杭州和泽医药科技有限公司,杭州310018

出　　处：《药物分析杂志》2020年第6期1113-1120,共8页Chinese Journal of Pharmaceutical Analysis

基　　金：杭州市农业与社会发展计划(20191203B26)。

摘　　要：目的:建立HPLC法测定复方制剂布洛芬盐酸曲马多片中2个有效成分布洛芬和盐酸曲马多的含量。方法:采用Agilent ZORBAX Extend-C18色谱柱(150 mm×4.6 mm,5μm),以乙腈-磷酸盐缓冲溶液(40∶60)为流动相,流速1.0 mL·min-1,检测波长264 nm,柱温25℃,进样量20μL,外标法定量。结果:布洛芬和盐酸曲马多质量浓度分别在39.60~396.0μg·m L-1(r=1.000)和8.104~81.04μg·m L-1(r=1.000)范围内呈良好线性关系。布洛芬和盐酸曲马多的平均回收率(n=9)分别为99.8%、99.9%,RSD分别为1.1%、1.2%。结论:所建立的方法简便、快速、准确,重复性好,可用于复方布洛芬盐酸曲马多片有效成分的测定。Objective:To established an HPLC method for determining the content of ibuprofen and tramadol hydrochloride in compound preparation of ibuprofen and tramadol hydrochloride tablets. Methods:Agilent ZORBAX Extend-C18 column(150 mm×4.6 mm,5 μm)was adopted with the mobile phase of acetonitrilephosphate buffer solution(40∶60)at the flow rate of 1.0 mL·min-1;detection wavelength was 264 nm;column temperature was 25 ℃;injection volume was 20 μL.External standard method for quantitative analysis was used.Results:The calibration curves of ibuprofen and tramadol hydrochloride were in good linear relation in the ranges of 39.60-396.0 μg·mL-1(r=1.000),and 8.104-81.04 μg·mL-1(r=1.000).The average recoveries of ibuprofen and tramadol hydrochloride(n=9)were 99.8% and 99.9%,RSDs were 1.1% and 1.2% respectively.Conclusion:The method is simple,rapid,accurate and reproducible.It can be used to determine the effective components of compound ibuprofen and tramadol hydrochloride tablets.

关 键 词：高效液相色谱 复方制剂 布洛芬 盐酸曲马多 有效成分 滤膜吸附 含量测定 

分 类 号：R917[医药卫生—药物分析学]