用萃取分光光度荧光法测定人血浆中醋酸氟卡尼的含量。

Measurement of flecainide acetate in human plasma by an extraction spectrophotofluorometric method.

作者信息

Chang S F, Miller A M, Jernberg M J, Ober R E, Conard G J

出版信息

Arzneimittelforschung. 1983;33(2):251-3.

Abstract

A fluorometric method for the quantitation of 2,5-bis-(2,2,2-trifluoroethoxy)-N-(2-piperidylmethyl)benzamide acetate (R-818, flecainide acetate) in human plasma has been developed. The minimum quantifiable concentration of flecainide acetate by this method is 25 ng/ml with a 2 ml plasma sample; a slightly modified procedure which also requires the use of a microcell in the spectrophotofluorometer further increases the maximum sensitivity to 12.5 ng/ml. The precision, expressed as relative standard deviation is 2.9, 0.7, 5.6, 3.5, and 4.3% for 75, 150, 250, 500, and 700 ng flecainide acetate/ml, respectively. The accuracy, expressed as relative error, is -6.7, -3.3, -0.4, +4.4, and -0.4%, respectively, for the corresponding concentrations specified above. The relative standard deviations for the inter-day variation are 19, 7, 9, 9, 8, 10, 13, 12, and 9% for the 25, 50, 100, 200, 300, 400, 600, 800, and 1000 ng/ml standards, respectively. Preliminary data indicate that propranolol and quinidine interfere with this method while procainamide, disopyramide, hydralazine, methyldopa, diazepam, hydrochlorothiazide, and sulfinpyrazone exhibit little or no interference. The results of the analyses of clinical samples by the fluorometric method agree well with an established GLC method. Thus, the quality of the fluorometric method is considered adequate for estimating plasma flecainide acetate levels during drug therapy in most non-research settings, if careful consideration is given to possible interference by other drugs.

摘要

已开发出一种荧光法用于定量测定人血浆中的2,5 - 双 -（2,2,2 - 三氟乙氧基）- N -（2 - 哌啶基甲基）苯甲酰胺醋酸盐（R - 818，醋酸氟卡尼）。用该方法测定醋酸氟卡尼时，2ml血浆样品的最低可定量浓度为25ng/ml；一种稍作改进的方法（该方法在分光荧光计中也需要使用微池）可将最大灵敏度进一步提高至12.5ng/ml。以相对标准偏差表示的精密度，对于醋酸氟卡尼浓度为75、150、250、500和700ng/ml时，分别为2.9%、0.7%、5.6%、3.5%和4.3%。以相对误差表示的准确度，对于上述相应浓度分别为 - 6.7%、 - 3.3%、 - 0.4%、 + 4.4%和 - 0.4%。25、50、100、200、300、400、600、800和1000ng/ml标准品日间变化的相对标准偏差分别为19%、7%、9%、9%、8%、10%、13%、12%和9%。初步数据表明，普萘洛尔和奎尼丁会干扰该方法，而普鲁卡因胺、丙吡胺、肼屈嗪、甲基多巴、地西泮、氢氯噻嗪和磺吡酮几乎不产生干扰或无干扰。荧光法分析临床样品的结果与既定的气相色谱法结果吻合良好。因此，如果仔细考虑其他药物可能产生的干扰，在大多数非研究环境中，荧光法的质量被认为足以用于估计药物治疗期间血浆醋酸氟卡尼的水平。