HPLC测定氨酚伪麻美芬片Ⅱ/氨麻苯美片中对乙酰氨基酚血药浓度

HPLC Determination of Acetaminophen in Human Plasma

关键词:  对乙酰氨基酚  高效液相色谱法  血药浓度

Key words:  acetaminophen  HPLC  blood drug concentration

摘要:

目的建立高效液相色谱法测定氨酚伪麻美芬片Ⅱ/氨麻苯美片中对乙酰氨基酚的血药浓度。方法血浆样品用6%高氯酸沉淀蛋白。色谱柱为Zorbax Eclipse XDB-C18柱（150 mm×4.6 mm, 5 μm），流动相为0.02 mol·L-1甲酸铵溶液（含甲酸0.2%）-甲醇-乙腈（91∶4.5∶4.5），流速为1.0 mL·min-1，紫外检测波长245 nm。结果血浆中内源性物质对样品测定无干扰。本方法线性范围为0.1～20 μg·mL-1 (r=0.999 6)，最低定量浓度为0.1 μg·mL-1，方法回收率为99.8%～101.5%，日内、日间RSD均小于12%。结论本法简便、准确，适用于对乙酰氨基酚药代动力学的研究。

Abstract:

OBJECTIVE To establish an HPLC method for the determination of acetaminophen in the plasma of volunteers who were administrated the compound tablets of acetaminophen, pseudoephedrine hydrochloride and dextromethorphan hydrobromide or acetaminophen, pseudoephedrine hydrochloride, diphenhydramine hydrochloride and dextromethorphan hydrobromide.METHODS Proteins in plasma samples were precipitated by 6% perchloric acid. A Zorbax Eclipse XDB-C18 was used with the mobile phase of 0.02 mol·L-1 ammonium formate solution(contained 0.2% formic acid)-methanol-acetonitrile (91∶4.5∶4.5) at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 245 nm. RESULTS The endogenous substance in plasma did not interfere with the determination of the samples. The linear range was 0.1～20 μg·mL-1(r=0.999 6), and the limit of quantitation was 0.1 μg·mL-1. The method recovery was 99.8%-101.5%. Both within-day RSD and between-day RSD were less than 12%.CONCLUSION The method was simple and accurate. It was suitable for the pharmacokinetic study of acetaminophen.