高效液相法测定复方氨酚烷胺片中对乙酰氨基酚含量

Content Determination of Paracetamol in Compound Paracetamol and Amantadine Hydrochloride Tablets by HPLC

目的 采用HPLC方法对复方氨酚烷胺片中对乙酰氨基酚含量进行检测,探讨该检测方法在复方氨酚烷胺片质控中的价值。方法 采用Agilent C18（250mm×4.6mm×5μm）色谱柱、水-甲醇（60∶40）流动相、20μL进样量、检测波长为273nm进行测定。结果 对乙酰氨基酚和其他杂质具有良好的分离效果,当其浓度为0.2499~1.2499mg·m L-1的时候,具有良好的线性关系,平均回收率为99.6%,RSD为1.5%。结论采用HPLC检测复方氨酚烷胺片中的对乙酰氨基酚含量操作简单,检出快速准确,能够有效排除温度等外在因素的影响,值得应用。

OBJECTIVE To use the HPLC method to detect the content of paracetamol in compound paracetamol and amantadine hydrochloride tablets, to explore the detection method in the quality control of compound paracetamol and amantadine hydrochloride tablets. METHODS Agilent Cls （250mm × 4. 6mm, 5μm） chromatographic column, methanol-water （60：40） as mobile phase, 20μL sample volume, the detection wavelength was 273nm. RESULTS Acetaminophen had been well separated form impurities, and had a good liner relationship between the concentration of 0. 2499 - 1. 2499mg · mL-1 , the average recovery was 99. 6%, RSD was 1.5%. CON- CLUSION The HPLC determination of the paracetamol content in compound paracetamol and amantadine hydrochloride tablets is simple operation, detected quickly and accurately, and could effectively eliminate the temperature in the external factors, it was worthy of application.