Pharmaceutical Analytical Chemistry Department, University of Alexandria, Egypt.
Drug Test Anal. 2010 Oct;2(10):489-93. doi: 10.1002/dta.160.
Amlodipine, a dihydropyridine calcium channel blocker, and valsartan, an angiotensin II receptor blocker, are co-formulated in a single-dose combination for the treatment of hypertension. The combination is used by patients whose blood pressure is not adequately controlled on either component monotherapy. This work describes a simple, sensitive, and reliable spectrofluorimetric method for the simultaneous determination of the two antihypertensive drugs; amlodipine besylate (AML) and valsartan (VAL) in their combined tablets. The method involved measurement of the native fluorescence at 455 nm (λ(Ex) 360 nm) and 378 nm (λ(Ex) 245 nm) for AML and VAL, respectively. Analytical performance of the proposed spectrofluorimetric procedure was statistically validated with respect to linearity, ranges, precision, accuracy, selectivity, robustness, detection, and quantification limits. Regression analysis showed good correlation between fluorescence intensity and concentration over the concentration ranges 0.2-3.6 and 0.008-0.080 µg mL⁻¹ for AML and VAL, respectively. The limits of detection were 0.025 and 0.0012 µg mL⁻¹ for AML and VAL, respectively. The proposed method was successfully applied for the assay of the two drugs in their combined pharmaceutical tablets with recoveries not less than 98.85%. No interference was observed from common pharmaceutical additives. The results were favourably compared with those obtained by a reference spectrophotometric method.
氨氯地平，一种二氢吡啶钙通道阻滞剂，和缬沙坦，一种血管紧张素 II 受体拮抗剂，在单剂量联合中被共同配方用于治疗高血压。该联合用于那些血压在单一药物治疗下不能充分控制的患者。这项工作描述了一种简单、灵敏、可靠的分光荧光法，用于同时测定两种抗高血压药物；苯磺酸氨氯地平（AML）和缬沙坦（VAL）在其复方片剂中的含量。该方法涉及到在 455nm（λ（Ex）360nm）和 378nm（λ（Ex）245nm）处分别测量 AML 和 VAL 的本征荧光。所提出的分光荧光法的分析性能在统计学上是根据线性、范围、精密度、准确度、选择性、稳健性、检测限和定量限进行验证的。回归分析显示，荧光强度与浓度之间有很好的相关性，AML 和 VAL 的浓度范围分别为 0.2-3.6 和 0.008-0.080μg mL⁻¹。AML 和 VAL 的检测限分别为 0.025 和 0.0012μg mL⁻¹。该方法成功地应用于两种药物在复方片剂中的测定，回收率不低于 98.85%。没有观察到常见的药物添加剂有干扰。结果与参考分光光度法得到的结果进行了有利的比较。
