摘要
目的建立同时测定曲马氨酚片中盐酸曲马多和对乙酰氨基酚含量的HPLC测定法。方法色谱柱为DiamasilC18柱 ,流动相为乙腈 0 0 0 5mol·L-1NH4H2 PO4(含 0 0 1mol·L-1三乙胺 ,pH3 2 ,V∶V =1∶4 3 ) ,检测波长为 2 1 5nm ,柱温为 3 5℃ ,流速 :1 0mL·min-1,进样 1 0 μL。结果盐酸曲马多和对乙酰氨基酚分别在质量浓度 9 92～ 49 60mg·L-1和 85 3 4～ 42 6 70mg·L-1内呈良好的线性相关性 ,相关系数r分别为 0 9999和0 9998。方法精密度RSD分别为 0 7%和 0 1 % (n=6) ,平均回收率分别为 1 0 0 1 %和 1 0 0 0 % ,方法RSD分别为 0 1 %和 0 1 % (n=9)。结论可同时测定盐酸曲马多和对乙酰氨基酚的含量 ,可用于多批样品的质量控制。
Objective To establish a HPLC method for simultaneous determination of the contents of tramadol hydrochloride and paracetamol in their compound tablets.Method Chromatographic condition included Diamasil C18(4.6 mm×200 mm,5 μm) column and mobile phase consisting of a mixture of acetonitrile- 0.005 mol·L-1 NH4H2PO4 solution containing 0.01 mol·L-1 triethylamine(pH3.2) =1∶4.3(V∶V).The detection wavelength was 215 nm.The flow rate was 1.0 mL·min-1.Result The method has a good linearity and correlation coefficient:the tramadol hydrochloride was between 9.92～49.60 μg·mL-1,the paracetamol was between 85.34～426.70 μg·mL-1.The recoveries were 100.1% and 100.0%,RSD were 0.1% and 0.1% respectively.Conclusion This method is a simple,rapid and accurate assay,and suitable for quality control of large amounts of samples.
出处
《沈阳药科大学学报》
CAS
CSCD
2004年第2期111-113,123,共4页
Journal of Shenyang Pharmaceutical University
