Anwar Basma H, Abdelhamid Nessreen S, Magdy Maimana A, Naguib Ibrahim A
Beni-Suef University, Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Alshaheed Shehata Ahmad Hegazy St, 62514, Beni-Suef, Egypt.
Taif University, College of Pharmacy, Department of Pharmaceutical Chemistry, Al-Hawiah 21974, Taif, Saudi Arabia.
J AOAC Int. 2020 Jan 1;103(1):132-139. doi: 10.5740/jaoacint.19-0069.
Dapoxetine (DAP) is a serotonin-norepinephrine reuptake inhibitor, and Tadalafil (TAD) is a phosphodiesterase type-5 inhibitor. Both are coformulated as tablets called Erectafil® for treatment of erectile ejaculation.
DAP and TAD were analyzed in their binary mixtures and pharmaceutical formulations using two multivariate calibration chemometric models.
Partial least-squares (PLS) and linear support vector regression (SVR) models were applied using two factor-four level experimental design and UV-spectrophotometric data. They were compared to each other, and their advantages and disadvantages were discussed.
The developed methods succeeded to determine DAP and TAD in different ratios with good results regarding International Conference on Harmonization guidelines. Linearity ranges were 2-15 μg/mL and 3-30 μg/mL for DAP and TAD, respectively, with good accuracy of 100 ± 0.37 for DAP and 100 ± 0.8 for TAD regarding PLS model and 100.04 ± 0.32 for DAP and 99.89 ± 0.77 for TAD regarding SVR model. Good precision values of 0.787 for DAP and 0.793 for TAD regarding PLS model and 1.105 for DAP and 0.930 for TAD regarding SVR model were obtained. The two models were applied on the dosage forms and statistically compared with the published HPLC method with no significant difference regarding accuracy and precision.
The two models can be utilized for routine analysis and QC of DAP and TAD in their bulk and pharmaceutical formulations. The SVR model gives better results and generalization ability than those of the PLS model regarding accuracy and prediction error, while the latter is better for being simpler and faster.
达泊西汀（DAP）是一种5-羟色胺-去甲肾上腺素再摄取抑制剂，他达拉非（TAD）是一种5型磷酸二酯酶抑制剂。二者共同制成名为Erectafil®的片剂用于治疗勃起功能障碍。
使用两种多元校正化学计量学模型分析DAP和TAD的二元混合物及药物制剂。
采用二因素四水平实验设计和紫外分光光度数据，应用偏最小二乘法（PLS）和线性支持向量回归（SVR）模型。对二者进行比较，并讨论其优缺点。
所建立的方法成功测定了不同比例的DAP和TAD，符合国际协调会议指南要求。DAP和TAD的线性范围分别为2-15μg/mL和3-30μg/mL，PLS模型下DAP和TAD的准确度分别为100±0.37和100±0.8，SVR模型下DAP和TAD的准确度分别为100.04±0.32和99.89±0.77。PLS模型下DAP和TAD的精密度分别为0.787和0.793，SVR模型下DAP和TAD的精密度分别为1.105和0.930。将这两种模型应用于剂型分析，并与已发表的高效液相色谱法进行统计学比较，在准确度和精密度方面无显著差异。
这两种模型可用于DAP和TAD原料药及药物制剂的常规分析和质量控制。在准确度和预测误差方面，SVR模型比PLS模型给出的结果更好且具有更强的泛化能力，而PLS模型则因更简单快速而更具优势。
