高效液相色谱法测定复方对乙酰氨基酚片的含量和溶出度

目的:建立测定复方对乙酰氨基酚片含量和溶出度的方法。方法:采用高效液相色谱法。色谱条件:采用SHIMADZUShim-pack C18色谱柱,流动相为甲醇-0.1%醋酸钠溶液(冰醋酸调节pH 3.5)(30∶70),流速1.0 mL.min-1,检测波长272nm。按中国药典桨法,采用ZRS-8G智能溶出仪,以0.1 mol.L-1盐酸溶液为溶出介质测定溶出度。结果:对乙酰氨基酚、咖啡因、阿司匹林线性范围分别为6.462～161.55μg.mL-1(r=0.9999),1.577～39.42μg.mL-1(r=0.9999),11.04～276.1μg.mL-1(r=0.9999);回收率(n=5)分别为100.1%,100.4%,99.8%,RSD分别为0.53%,0.70%,0.55%。样品溶出度均一性好,在30 min时3个组分溶出度均达到80%。结论:本方法准确、方便,结果满意,适用于复方对乙酰氨基酚片的含量和溶出度测定。

HPLC determination of the content and dissolution of compound paracetamol tablets

Objective: To establish an RP-HPLC method for the determination content and dissolution of compound paracetamol tablets.Methods: HPLC analysis was carried out by using SHIMADZU Shim-pack C18 column and a mixture of methanol and 0.1% sodium acetate adjusted to pH 3.5 with acetic acid glacial(30∶ 70,) as mobile phase.The flow rate was 1.0 mL.min-1,and the detection wavelength was 272 nm.Results: The calibration curves for paracetamol,caffeine and aspirin were linear over the ranges of 6.462-161.55 μg.mL-1(r = 0.9999),1.577-39.42 μg.mL-1(r = 0.9999),11.04-276.1 μg.mL-1(r = 0.9999),respectively;The average recoveries(n = 5) were 100.1%,100.4%,99.8%,and RSD were 0.53%,0.70%,0.55%.The dissolution of different batches of compound paracetamol tablets fulfilled the requirements and had the similar nature.Conclusion: This method is accurate,convenient and suitable for determination content and dissolution of compound paracetamol tablets.