HPLC法测定盐酸曲马多葡萄糖注射液中盐酸曲马多的含量

摘要

目的:建立HPLC法测定盐酸曲马葡萄糖注射液中盐酸曲马多的含量.方法:色谱柱:Bondysil-C18(250 mm×4.6 mm,5 μm),流动相:醋酸-冰醋酸钠缓冲液(pH4.5)-甲醇(65:35),流速:1.0 ml·min-1,柱温:35℃,检测波长:271 nm,进样量:20 μl.结果:盐酸曲马多质量浓度线性范围为10~140μg·ml-1(r=0.999 0),平均回收率为99.9%(RSD=0.80%,n=9).结论:本方法简便、灵敏、准确.%Objective: To establish an HPLC method for the determination of tramadol hydrochloride in tramadol hydrochloride glucose injections. Method: The analysis was performed on a Bondysil-C18( 250 mm ×4.6 mm,5 μm )column. The mobile phase was acetic acid-sodium glacial acetic acid buffer ( pH 4.5) and methanol ( 65: 35 ). The flow rate was 1.0 ml · min-1, the column temperature was 30℃ , the detection wavelength was 271 nm, and the injection volume was 20 μl. Result: The linear range of tramadol hydrochloride was 10-140 μg · ml-1( r = 0.999 0 ), and the average recovery was 99.9% with RSD of 0.80%( n = 9 ). Conclusion: The method is simple, sensitive and accurate.