高效液相法(HPLC)测定复方氨酚烷胺颗粒中两种组分的含量

Determination of the Major Components in Compound Paracetamol and Amantadine Hydrochloride Granules byHPLC

采用HPLC法测定复方氨酚烷胺颗粒中对乙酰氨基酚和马来酸氯苯那敏的含量。测试方法:色谱柱为Alltima-C18柱(250 mm×4.6 mm,5μm);流动相为甲醇-0.05 mol/L磷酸二氢钠(40∶60);流速为1.0 mL/min;检测波长为215 nm;磷酸调pH至2.60;柱温25℃。结果显示:对乙酰氨基酚和马来酸氯苯那敏分别在0.160224～0.240336 mg/mL和0.013464～0.020196 mg/mL范围内浓度与峰面积呈良好线性关系;平均回收率对乙酰氨基酚为101%(RSD=0.5%);马来酸氯苯那敏为100%(RSD=0.9%)。本法简便、快速、准确,可用于复方氨酚烷胺颗粒的含量测定。

A HPLC method for determining the contents of paracetamol and chlorphenamine maleate in compound paracetamol and amantadine hydrochloride granules was established. The experiment was performed on Alltima -C18 （4.6 mm ×250 mm, 5 μm） column, using the mixture of methanol -0. 05 mol/L sodium dihydrogen phosphate （40 ： 60） as the mobile phase. Flow rate was 1.0 mL/min, the detection wavelength was set at 215 nm, pH was adjusted to 2. 60 with phosphoric acid, and the column temperature was maintained at 25 ℃. The linearity of peak area was good when the con- centration of paracetamol and chlorpheniramine maleate was in the ranges of 0. 160224 - 0. 240336 mg/mL and 0. 013464 0. 020196 mg/mL, respectively. The average recovery of paracetamol was 101% （RSD = 0.5% ） and chlorphenamine maleate was 100% （ RSD = 0. 9% ）. This method was simple, accurate and sensitive and can be used for the determination of paracetamol and chlorphenamine maleate in compound paracetamol and amantadine hydrochloride granules.