Radwan Aya Saad, Magdy Galal, El-Maghrabey Mahmoud, Mansour Fotouh R, Al-Khateeb Lateefa A, Mahdi Wael A, Alshehri Sultan, Alsehli Bandar R, Alsaggaf Wejdan T, Abd Alrheam Ali I, El Hamd Mohamed A
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh, 33511, Egypt.
J Fluoresc. 2024 Dec 14. doi: 10.1007/s10895-024-04064-2.
Hypertension is the predominant risk factor for cardiovascular diseases and mortality. This study presents the first method for the simultaneous analysis of the co-administered antihypertensive drugs, Carvedilol (CAR) and Telmisartan (TEL) using a fast, highly sensitive, environmentally friendly, and cost-effective second derivative synchronous spectrofluorimetric approach. The fluorescence of CAR and TEL was quantified at 243 nm and 274.4 nm, respectively. The measurement was conducted using a wavelength difference (Δλ) of 100.0 nm. The proposed technique showed remarkable linearity (r = 0.9999) within the defined concentration ranges for CAR (1.0-20.0 ng/mL) and TEL (1.0-50.0 ng/mL). The results showed that the suggested approach has very high sensitivity, with limits of detections of 0.247 and 0.120 ng/mL for CAR and TEL, respectively. This indicates that the developed technique is suitable for bioanalytical purposes. The within-run precisions, including both inter-day and intra-day variations, for both analytes were found to be less than 0.79% RSD. The implemented method was successfully utilized to concurrently determine the specified pharmaceuticals in both tablet dosage forms and human plasma samples, resulting in excellent %recoveries and low % RSD values. The method's exceptional greenness and eco-friendliness were demonstrated by the GAPI and AGREE metrics. Moreover, the practicality, applicability, and economical nature of the method were assessed using BAGI tool. The three metrics showed how practical and sustainable the new approach is, and how well it can be applied for the regular analysis of the studied drugs. The ICHQ2 (R1) criteria were followed for the validation of the suggested approach.
高血压是心血管疾病和死亡的主要危险因素。本研究提出了第一种同时分析联合使用的抗高血压药物卡维地洛（CAR）和替米沙坦（TEL）的方法，该方法采用快速、高灵敏度、环境友好且经济高效的二阶导数同步荧光光谱法。CAR和TEL的荧光分别在243nm和274.4nm处进行定量。测量使用100.0nm的波长差（Δλ）进行。所提出的技术在CAR（1.0 - 20.0 ng/mL）和TEL（1.0 - 50.0 ng/mL）的定义浓度范围内显示出显著的线性（r = 0.9999）。结果表明，所建议的方法具有非常高的灵敏度，CAR和TEL的检测限分别为0.247和0.120 ng/mL。这表明所开发的技术适用于生物分析目的。两种分析物的批内精密度，包括日间和日内变化，均小于0.79% RSD。所实施的方法成功用于同时测定片剂剂型和人血浆样品中的特定药物，回收率极佳，RSD值较低。GAPI和AGREE指标证明了该方法具有出色的绿色度和环境友好性。此外还使用BAGI工具评估了该方法的实用性、适用性和经济性。这三个指标表明了新方法的实用性和可持续性，以及它在研究药物常规分析中的应用效果。所建议的方法按照ICHQ2（R1）标准进行验证。
