Hoppe U, Krüdewagen B, Stein H, Hertrampf R, Gundert-Remy U
Institut für Arzneimittel des Bundesgesundheitsamtes, Berlin, Germany.
Int J Clin Pharmacol Ther Toxicol. 1993 Mar;31(3):142-7.
The precision and accuracy of HPLC and FPIA for the measurement of flecainide plasma levels were compared below, in and above the therapeutic range (200-1,000 ng/ml). Following a calibration crossover study, five standard plasma solutions of varying flecainide concentrations (SPS) and 99 flecainide containing plasma samples of 24 in-patients (IPS) were analyzed with both methods. The results show that within the range of approximately 500-1,500 ng/ml, the two methods did not differ in either precision (expressed as coefficient of variation, CV) or accuracy (expressed as relative error, RE). Close to the lower limit and below the therapeutic range however, HPLC provided greater precision and accuracy than FPIA.
下面比较了高效液相色谱法(HPLC)和荧光偏振免疫分析法(FPIA)在治疗范围(200 - 1000 ng/ml)以下、范围内及以上测定氟卡尼血浆水平时的精密度和准确性。在校准交叉研究之后,用这两种方法分析了五种不同氟卡尼浓度的标准血浆溶液(SPS)以及99份来自24名住院患者的含氟卡尼血浆样本(IPS)。结果表明,在大约500 - 1500 ng/ml范围内,两种方法在精密度(以变异系数,CV表示)或准确性(以相对误差,RE表示)方面均无差异。然而,在接近下限且低于治疗范围时,HPLC比FPIA具有更高的精密度和准确性。