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建立并验证 HPLC-UV 法用于测定兔血浆中卡马西平的浓度。

Development and validation of an HPLC-UV method for the quantification of carbamazepine in rabbit plasma.

机构信息

Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia ; Department of Pharmaceutics, college of Pharmacy, Al-Azhar University.

出版信息

Saudi Pharm J. 2012 Jan;20(1):29-34. doi: 10.1016/j.jsps.2011.04.003. Epub 2011 Apr 24.

Abstract

An isocratic simple rapid assay has been developed and validated for the determination of carbamazepine (CBZ) in both solution form and rabbit plasma using propylparaben as an internal standard. The assay was performed using a μ-Bondapak C18 (150 mm × 4.6 mm i.d) with a mobile phase consisting of methanol and water (50:50), the flow rate was 1 ml/min and UV detection at 285 nm. The method was found to be specific for CBZ, no interfering peaks were observed with an overall analytical run time of 15 min. Accuracy reported as % recovery were found to be 98.37-100.45% and 97.53-103.58% for inter-day and intra-day accuracies, respectively. Inter-day precision (reproducibility) was found to be 0.53-2.75% RSD, while intra-day precision (repeatability) was found to be 1.06-3.7% RSD for the samples studied. The calibration curve was found to be linear with the equation y = 0.2847x + 0.0138, with a correlation coefficient of 0.9999 (R (2)) over a concentration range of 0.5-40 μg/ml. The limit of quantitation was the lowest concentration. The method is simple and rapid and does not require any preliminary treatment of the sample. The method was fully validated.

摘要

已开发并验证了一种等度简单快速的测定法,可用于使用丙基对羟基苯甲酸酯作为内标,测定溶液形式和兔血浆中的卡马西平(CBZ)。该测定法使用μ-Bondapak C18(150mm×4.6mm id)进行,流动相由甲醇和水(50:50)组成,流速为 1ml/min,UV 检测波长为 285nm。该方法被发现对 CBZ 具有特异性,没有观察到干扰峰,总分析运行时间为 15 分钟。日内和日间准确度分别报告为 98.37-100.45%和 97.53-103.58%的回收率。日内精密度(重现性)为 0.53-2.75%RSD,而日间精密度(重复性)为 1.06-3.7%RSD。校准曲线呈线性,方程为 y=0.2847x+0.0138,相关系数为 0.9999(R 2),浓度范围为 0.5-40μg/ml。定量下限为最低浓度。该方法简单快速,不需要对样品进行任何预处理。该方法已完全验证。

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