高效液相色谱法同时测定氨酚曲马多片中2种组分的含量

Simultaneous determination of two constituents in compound tramadoi tablets

目的:建立高效液相色谱法测定氨酚曲马多片中盐酸曲马多和对乙酰氯基酚的含量。方法:以DiamonsilTMC18柱为色谱柱;采用甲醇-0．02 mol·L-1磷酸二氢钾溶液(45:55)为流动相,流速1．0 mL·min-1,检测波长为220 nm。结果:本方法可同时测定2个组分含量。盐酸曲马多和对乙酰氨基酚分别在10．8～37．8μg·mL-1和91．0～318．5μg·mL-1浓度范围内,峰面积与其浓度呈良好的线性关系,平均回收率和RSD范围分别为100．2％～100．5％和0．33％～0．46％;99．7％～100．4％和0．39％～0．54％。结论:本法简便、快速、结果准确,适用于该复方制剂的含量测定。

Objective： To establish a HPLC method for simultaneous quantification of tramadol hydrochloride and paracetamol in compound tramadol hydrochloride tablets. Methods： The two components could be assayed simultaneously by the HPLC consisted of a Diamonsil C18 column and an eluant of methyl alcohol-0. 02mol·L^-1 potassium phosphate monobasie （45： 55） with the flow rate of 1.0 mol·L^-1 and the detection wavelength at 220 nm. Results： The calibrated linear curves of tramadol and paracetamol were within the concentration of 10. 8 ～37.8μg·mL^-1 versus 91.0 ～ 318.5μg·mL^-1, respectively. The average recoveries of tramadol and paraeetamol were 100. 2% ～ 100. 5% （RSD were 0. 33%～ 0.46%） and 99. 7% ～ 100. 4% （RSD were 0. 39% ～0. 54% ）, respectively. Conclusion： This HPLC method can be used for simultaneously quantitative analysis of the two components in compound tramadol tablets.