Department of Chemistry, College of Science, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.
Department of Chemistry, College of Science, Imam Mohammad Ibn Saud Islamic University (IMSIU), Riyadh, Saudi Arabia.
PLoS One. 2024 Oct 7;19(10):e0311121. doi: 10.1371/journal.pone.0311121. eCollection 2024.
A ternary mixture incorporating Hydroxyzine hydrochloride (HYX), Ephedrine hydrochloride (EPH) and Theophylline (THP) frequently prescribed for the treatment of respiratory diseases. Herein, two spectrophotometric methods are designated and applied to resolve these three components in their mixture. Method A is ratio-subtraction combined with derivative spectrophotometry, where THP can be determined directly at its λmax 271 nm (neither HYX or EPH interfere), then for determination of HYX and EPH, the ternary mixture was divided by 22 μg/mL of THP and after subtraction of the plateau region, HYX can be determined directly at its λmax 234.2 nm (absence of EPH intervention). Finally, the third derivative (3D) spectrophotometric approach was utilized to estimate EPH by detecting the peak amplitude at 222 nm with Δλ = 4 and a scaling factor 100. Principal Component Regression (PCR) and Partial Least Squares (PLS), two multivariate calibration approaches, were applied effectively in Method B. This method effectively quantified the mixture under investigation by using the absorption spectra obtained from suitable solutions of the three components in the 210-230 nm region. The calibration models were evaluated using cross-validation with PCR and PLS, producing statistical characteristics that demonstrate the effectiveness of the calibration models. Synthetic and pharmaceutical preparations were also used to conduct external validation. In pharmaceutical formulation, these methods were successfully applied to analyze HYX, EPH, and THP without overlap from formulation's excipients. Moreover, the study's findings were statistically contrasted with those of earlier reported HPLC method. Appraisal approaches were used to determine whether the new spectrophotometric methods had an adverse environmental impact involving the Green Analytical Procedure Index (GAPI) and the AGREE (Analytical Greenness). These evaluations delivered information about the methods' eco-friendliness and sustainability, proving that they are in line with ecologically attributed practices. Furthermore, the Blue Applicability Grade Index (BAGI) was utilized to identify and verify the feasibility and practicality of the suggested approaches.
一种包含盐酸羟嗪（HYX）、盐酸麻黄碱（EPH）和茶碱（THP）的三元混合物，常用于治疗呼吸疾病。本文设计并应用了两种分光光度法来拆分混合物中的这三种成分。方法 A 是比值减法与导数分光光度法相结合，其中 THP 可直接在其λmax 271nm 处测定（既不干扰 HYX 也不干扰 EPH），然后对于测定 HYX 和 EPH，将三元混合物除以 22μg/mL 的 THP，并在扣除平台区域后，HYX 可直接在其λmax 234.2nm 处测定（不存在 EPH 的干扰）。最后，采用三阶导数（3D）分光光度法，通过检测 222nm 处的峰振幅（Δλ=4，比例因子 100）来估计 EPH。主成分回归（PCR）和偏最小二乘法（PLS）两种多元校正方法在方法 B 中得到了有效应用。该方法通过使用三元混合物在 210-230nm 区域的合适溶液的吸收光谱，有效地对混合物进行定量。使用 PCR 和 PLS 进行交叉验证评估校准模型，产生了表明校准模型有效性的统计特征。还使用合成品和制剂进行了外部验证。在药物制剂中，这些方法成功地用于分析 HYX、EPH 和 THP，没有制剂辅料的重叠。此外，还对研究结果与先前报道的 HPLC 方法进行了统计学对比。评估方法用于确定新的分光光度法是否对环境产生不利影响，涉及绿色分析程序指数（GAPI）和 AGREE（分析绿色度）。这些评估提供了有关方法生态友好性和可持续性的信息，证明它们符合生态归因实践。此外，还使用蓝色适用性等级指数（BAGI）来识别和验证所建议方法的可行性和实用性。
