Alnajjar Ahmed O
King Faisal University, College of Science, Department of Chemistry, PO Box 400, Al-Ahssa 31982, Saudi Arabia.
J AOAC Int. 2011 Mar-Apr;94(2):498-502.
A rapid, simple, and sensitive capillary electrophoresis (CE) method was developed and validated for the simultaneous determination of amlodipine (AML) and valsartan (VAL) in pharmaceuticals and human plasma using a UV photodiode array detector. Electrophoretic conditions were optimized to improve separation, sensitivity, and rapidity. The optimal conditions were 25 mM phosphate buffer at pH 8.0, injection time 10.0 s, voltage 25 kV, and column temperature 25 degrees C, with detection at 214 nm. The method was found to be linear in the range of 1.0-35 and 1.0-350 mg/L, with weighted regression 0.9999 and 0.9994, for AML and VAL, respectively. Validation of the method showed acceptable intraday and interday accuracy (85.5-95.3%) and precision (RSD 1.64-4.2%) in pharmaceutical formulation and human plasma analysis. The sensitivity of the method was enhanced by both optimization of the CE procedure and preconcentration performed by liquid-liquid extraction. The LOD for both AML and VAL was 0.03 mg/L, which allows analysis at the level of the drugs possibly found in human plasma. Therefore, the proposed method is suitable for QC in pharmaceutical laboratories and therapeutic drug monitoring in clinical laboratories.
开发并验证了一种快速、简单且灵敏的毛细管电泳（CE）方法，该方法使用紫外光电二极管阵列检测器同时测定药物制剂和人血浆中的氨氯地平（AML）和缬沙坦（VAL）。对电泳条件进行了优化，以提高分离度、灵敏度和速度。最佳条件为pH 8.0的25 mM磷酸盐缓冲液、进样时间10.0 s、电压25 kV、柱温25℃，检测波长为214 nm。该方法在1.0 - 35 mg/L和1.0 - 350 mg/L范围内呈线性，AML和VAL的加权回归分别为0.9999和0.9994。该方法的验证表明，在药物制剂和人血浆分析中，日内和日间准确度（85.5 - 95.3%）和精密度（RSD 1.64 - 4.2%）均可接受。通过优化CE程序和液 - 液萃取进行预富集，提高了该方法的灵敏度。AML和VAL的检测限均为0.03 mg/L，这使得能够在人血浆中可能发现的药物水平上进行分析。因此，所提出的方法适用于制药实验室的质量控制和临床实验室的治疗药物监测。
