摘要
作者建立了测定普罗帕酮(propafenone,PF)的反相高效液相色谱方法。固定相为日立GEL 3056(ODS)。流动相为甲醇:醋酸钠缓冲液:水(70:15:15,v/v),并用二乙胺调至0.0584mol/L作为改性剂。流速为1ml/min。选择丁卡因作为内标准品。紫外检测波长250 nm。血浆中PF氢氧化钠碱化,用含2％(v/v)异戊醇的正庚烷溶液提取,再用0.3mol/L磷酸溶液回提直接进样。检测限10ng,血浆最低检测浓度40 ng/ml。方法的绝对回收率为88.82+6.39％,日内与日间的变异系数CV小于10％。在50～1600 ng/ml浓度范围内线性良好,相关系数r=0.9993。用本方法测定5名健康志愿者单剂量口服PF 300mg药动学参数的均值为:t_(1/2)(k_a)=0.40±0.15h;t_(1/2)(k)=2.81±0.52h;T_(max)=1.88±0.47h;C_(max)=631.67±453.13 ng/ml;AUC=3843.66±3032.80ng·h^(-1)·ml^(-1)。
A RP-HPLC method was described for the determination of plasma propafenone. The column was 25 cm×4. 0 mm ID stainless steel packed with ODS (5 μm). The mobile phase consisted of CH3OH: HAC-NaAC: H2O (70: 15: 15, v/v), containing 0. 0584 mol/L diethylamine as a modifier. The flow rate was 1. 0 ml/min. Tetracaine was used as a internal standard. Chromatography was performed at 250 run with variable wavelength ultraviolet detector. The propafenone was first extracted from alkalized plasma with 2.0 ml of 2% (v/v) isoamyl alcohol in n-heptane, and then reextracted with 0. 3 mol/L H3PO4, 100μl. Linear calibration curve for propafenone was measured over the range of 50-1600 ng/ml, and correlation coefficient was 0. 9993. The recovery rate of the method was 88.82±6.39% (n =5), and the coefficient of variation was less than 10% (n = 10). The lowest determined level was 40 ng/ml.The pharmacokinetic parameters were measured by this method in 5 healthy volunteers after a single oral dose propafenone 300 mg. The mean pharmacokinetic parameters were as follows: t1/2 (Ka=0. 40±0. 15 h, t1/2 (K) =2. 81±0. 52 h, Tmax= 1. 88±0. 47 h, Cmax= 631. 67±453. 13 ng/ml, and AUC= 3843.06±3032. 80ng·h-1·ml-1..
出处
《第二军医大学学报》
CAS
CSCD
北大核心
1990年第1期23-27,共5页
Academic Journal of Second Military Medical University
基金
第二军医大学青年科研基金
关键词
普罗帕酮
高效液相色谱
药代动务学
propafenone
HPLC
plasma concentration
pharmacokinetics
