荧光偏振免疫分析法与高效液相色谱法用于血清中苯妥英、苯巴比妥和卡马西平定量测定的比较。

Comparison of fluorescence polarization immunoassay and high performance liquid chromatography for the quantitative determination of phenytoin, phenobarbitone and carbamazepine in serum.

作者信息

Ashy A R, el-Sayed Y M, Islam S I

出版信息

J Pharm Pharmacol. 1986 Aug;38(8):572-7. doi: 10.1111/j.2042-7158.1986.tb03083.x.

DOI:10.1111/j.2042-7158.1986.tb03083.x

Abstract

The Abbott TDx fluorescence polarization immunoassay (FPIA) system has been evaluated and compared with well-established high performance liquid chromatography (HPLC) for the determination of three anticonvulsant drugs: phenytoin, phenobarbitone and carbamazepine. These assays were evaluated for precision, calibration curve stability, specificity and accuracy. Within-run precision studies using control samples (n = 15) in the subtherapeutic, therapeutic, and toxic concentrations, resulted in coefficients of variation in the range of 1.79-3.99% (FPIA) and 1.16-2.52% (HPLC), respectively. Between-run precision ranged from 2.32-6.34% for FPIA and from 2.04-3.38% for HPLC. Comparison of 122 patient samples assayed with both methods indicated an extremely good analytical correlation (r = 0.96) for all three comparisons. The FPIA method offers significant advantages in calibration curve stability while maintaining accuracy and precision comparable with those of established HPLC procedures.

摘要

已对雅培TDx荧光偏振免疫分析（FPIA）系统进行了评估，并与成熟的高效液相色谱法（HPLC）进行了比较，以测定三种抗惊厥药物：苯妥英、苯巴比妥和卡马西平。对这些分析方法的精密度、校准曲线稳定性、特异性和准确性进行了评估。使用亚治疗浓度、治疗浓度和中毒浓度的对照样品（n = 15）进行批内精密度研究，FPIA的变异系数范围为1.79 - 3.99%，HPLC的变异系数范围为1.16 - 2.52%。FPIA的批间精密度范围为2.32 - 6.34%，HPLC的批间精密度范围为2.04 - 3.38%。用两种方法检测的122份患者样品的比较表明，所有三项比较的分析相关性都非常好（r = 0.96）。FPIA方法在校准曲线稳定性方面具有显著优势，同时保持了与既定HPLC程序相当的准确性和精密度。