Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt; Department of Chemistry, University of Michigan, Ann Arbor, 48109, MI, United States.
Spectrochim Acta A Mol Biomol Spectrosc. 2024 Jan 15;305:123532. doi: 10.1016/j.saa.2023.123532. Epub 2023 Oct 14.
Fixed-dose combinations for treatment of hypertension are observed in many dosages in the global market because of their high efficacy compared to single component dosage forms. One of these effective combinations is atenolol/amlodipine which is usually administered to patients with hypertension. Hence, development of facile, accurate, and sensitive methods for simultaneous estimation of atenolol and amlodipine is of great importance for quality control testing and pharmacokinetic studies. In our study, we developed two spectrofluorimetric methods to estimate both compounds in different pharmaceuticals. The first method is based on the estimation of atenolol and amlodipine by double-scan conventional spectrofluorimetry where the fluorescence intensities of atenolol and amlodipine were measured at 299 and 434 nm after excitation at 274 and 358 nm, respectively. The second method depends on synchronous spectrofluorimetric measurements at Δλ = 70 nm, where atenolol is assayed at 266 nm and amlodipine is assayed at 363 nm. Methods' optimizations were carried out to select the optimum conditions that render high selectivity and sensitivity. Such optimizations included assessment of solvents, surfactants, buffer volumes and pHs. The conventional spectrofluorimetric method was rectilinear over concentration range of 30.0-300.0 ng mL for atenolol and 0.25-7.00 µg mL for amlodipine while the synchronous spectrofluorimetric method showed linearity over the ranges of 0.60-6.00 µg mL for atenolol and 0.25-7.00 µg mL for amlodipine with low detection limits (≤0.12 µg mL) for both compounds in the two methods. It is the first work that demonstrates estimation of atenolol and amlodipine in their combinations by conventional and synchronous spectrofluorimetry. Both methods were applied to estimate atenolol and amlodipine in different pharmaceuticals with high %recovery and low %RSD.
固定剂量组合治疗高血压在全球市场中观察到许多剂量，因为与单一成分剂型相比，它们具有更高的疗效。这些有效组合之一是阿替洛尔/氨氯地平，通常用于治疗高血压患者。因此，开发简便、准确、灵敏的同时测定阿替洛尔和氨氯地平的方法对于质量控制测试和药代动力学研究非常重要。在我们的研究中，我们开发了两种分光荧光法来测定不同制剂中的两种化合物。第一种方法是基于双扫描常规分光荧光法测定阿替洛尔和氨氯地平，其中阿替洛尔和氨氯地平的荧光强度分别在 274nm 和 358nm 激发下在 299nm 和 434nm 处测量。第二种方法依赖于同步分光荧光测量，其中 Δλ=70nm，在 266nm 处测定阿替洛尔，在 363nm 处测定氨氯地平。方法的优化是为了选择具有高选择性和灵敏度的最佳条件。这些优化包括评估溶剂、表面活性剂、缓冲液体积和 pH 值。常规分光荧光法在阿替洛尔的浓度范围为 30.0-300.0ng mL 和氨氯地平的浓度范围为 0.25-7.00μg mL 时呈线性，而同步分光荧光法在阿替洛尔的浓度范围为 0.60-6.00μg mL 和氨氯地平的浓度范围为 0.25-7.00μg mL 时呈线性，两种方法的检测限均较低（≤0.12μg mL）。这是首次通过常规和同步分光荧光法测定它们的组合中的阿替洛尔和氨氯地平的工作。两种方法均用于测定不同制剂中的阿替洛尔和氨氯地平，回收率高，RSD 低。
