Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, 11835 Cairo, Egypt.
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, ET-11562 Cairo, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2022 Nov 5;280:121523. doi: 10.1016/j.saa.2022.121523. Epub 2022 Jun 18.
Recent studies have reported that using certain antihypertensive therapies such as angiotensin II receptor blockers (ARBs) and calcium channel blocker (CCBs) is associated with reduction of fatal outcomes and improving clinical characteristics of patients suffering from hypertension during coronavirus pandemic. Thus, in the current work an effective, innovative and eco-friendly spectrophotometric manner namely, parent spectrum extraction (PSE)was established for evaluation of recommended triple antihypertensive combination therapies incorporate valsartan (VAL) as ARBs, amlodipine besylate as CCBs (AML) and hydrochlorothiazide (HCT)as diuretic into single-pill in challengeable ratio. PSE manner composed of two complementary steps, auxiliary resolution coupled with data analysis resolution(DAR)and it is characterized by resolving the spectral bands of the drugs and extraction of their discrete parent spectra (D); accordingly, enabling determination of each analyte at its λ. Auxiliary resolution of AML in triple mixture was applied to decrease complexity of overlapped spectra via constant multiplication (CM) followed by spectrum subtraction (SS) to obtain resolved mixture of VAL and HCT while data analysis resolution (DAR) of this binary mixture was applied via one of three novel methods namely, absorbance extraction (AE), peak-amplitude extraction (PE) and ratio extraction (RE) along with SS method. The proposed methods had analyzed VAL, AML and HCT in the range of 4.0-44.0 µg/mL, 4.0-40.0 µg/mL and 2.0-24.0 µg/mL, respectively with an excellent correlation coefficient (r ≥ 0.9999). Further, the proposed methods in PSR manner were validated as stated by ICH guidelines and it was found that accuracy and precision results are within the acceptable limit. The suggested procedures were effectively utilized for the concurrent quantification of VAL, AML and HCT in synthetic mixtures and tablets. The greenness of the proposed spectrophotometric methods was evaluated by National Environmental Methods Index (NEMI), the Analytical Eco-Scale, the Green Analytical Procedure Index (GAPI) and Analytical greenness metric (AGREE) where the four tools affirmed the eco-friendly nature of the proposed methods. A comparison between the outcomes of the studied methods with the official and reported ones was performed and no statistical difference was arisen between the methods regarding to accuracy and precision.The achieved results along with the simplicity, affordability and low-cost of the proposed methods recommended their appropriateness for the regular quality control examination and analysis of pure materials and pharmaceutical formulations as well as their applicability for the spectralprint recognition of the studied drugs.
最近的研究报告指出，使用某些降压治疗方法，如血管紧张素 II 受体阻滞剂（ARB）和钙通道阻滞剂（CCB），与降低致命结局和改善高血压患者的临床特征有关，而这些患者正值冠状病毒大流行期间。因此，在目前的工作中，建立了一种有效的、创新的和环保的分光光度法，即母体光谱提取（PSE），用于评估推荐的三联抗高血压联合治疗方案，其中包括缬沙坦（VAL）作为 ARB、苯磺酸氨氯地平（AML）作为 CCB 和氢氯噻嗪（HCT）作为利尿剂，以挑战性的比例制成单一药丸。PSE 方法由两个互补的步骤组成，辅助解析与数据分析解析（DAR），其特点是解析药物的光谱带并提取其离散的母体光谱（D）；因此，能够在其 λ 处测定每个分析物。在三元混合物中应用 AML 的辅助解析通过常数乘法（CM）降低重叠光谱的复杂性，然后进行光谱减法（SS）以获得 VAL 和 HCT 的已解析混合物，而二元混合物的数据分析解析（DAR）通过三种新方法之一应用，即吸光度提取（AE）、峰幅度提取（PE）和比提取（RE）以及 SS 方法。所提出的方法已在 4.0-44.0 μg/mL、4.0-40.0 μg/mL 和 2.0-24.0 μg/mL 范围内分析了 VAL、AML 和 HCT，相关系数（r≥0.9999）极好。此外，根据 ICH 指南验证了 PSR 方式下提出的方法，发现准确度和精密度结果在可接受范围内。所提出的程序已有效地用于合成混合物和片剂中 VAL、AML 和 HCT 的同时定量。通过国家环境方法指数（NEMI）、分析生态标度、绿色分析程序指数（GAPI）和分析绿色度指标（AGREE）评估所提出的分光光度法的绿色度，这四个工具都肯定了所提出方法的环保性质。对所研究方法的结果与官方和报告结果进行了比较，发现方法在准确度和精密度方面没有统计学差异。所获得的结果以及所提出方法的简单性、可负担性和低成本，建议将其用于常规质量控制检查和分析纯物质和药物制剂，以及用于研究药物的光谱打印识别。
