复方氨酚那敏缓释片的含量测定

Determination of compound anfennamin sustained tablets

目的:建立复方氨酚那敏缓释片申扑热息痛、咖啡因和马来酸氯苯那敏的含量测定方法。方法:高相液相色谱法。以Phenemax C_(18)(4.6 mm×250 mm,5 μm)柱为固定相,乙腈-水-磷酸(11:89:0.5,三乙胺调节 pH=3.0)为流动相,检测波长210 nm,流速1 mL·min^(-1)。结果:复方氨酚那敏缓释片中3种有效成分扑热息痛、咖啡因、马来酸氯苯那敏的回归方程分别为 Y=29280X+80970(r=0.9997)、Y=55980X+65930(r=0.9998)、Y=15940X+2786(r=0.9998),线性范围分别为12～118,8～48,2～16μg·mL^(-1);平均回收率(n=9)分别为100.0%(RSD=1.1%),99.74%(RSD=1.0%),100.8%(RSD=0.73%)。结论:该方法分离度良好,灵敏度高,准确且简便易行。

Objective： A HPLC method for determination of compound anfennamin sustained tablets was establishad. Methods： A Phenemax C18 （4.6 mm×250 mm, 5 μm） column was usod, with the mobile phase of acetonitrile - water - phosphoric acid （11 ： 89： 0.5） and adjust pH to 3.0 by triethylamine, at the detection wavelength of 210 nm. Results： The standard curve of paracetamol, caffeine and chlorphenamine maleate was Y = 29280X ＋ 80970 （r = 0.9997）, Y = 55980X ＋ 65930 （r = 0.9998） and Y = 15940X ＋ 2786 （r = 0.9998） respectively. The calibration curves were linear in the range of 12 - 118 μg·mL^-1 for paracetamol, 8 -48 μg·mL^-1 for caffeine, 2 - 16 μg·mL^-1 for chlorphenamine maleate. The average recoveries （n = 9） of paracetamol, caffeine and chlorphenamine maleate were 100.0% （RSD = 1.1%）, 99.74% （RSD = 1.0%）and 100.8% （RSD = 0.73%） respectively. Conclusion： The proposed method is well detached degree, highly sensitive, well accurate and simple.