Linear Support Vector Regression and Partial Least-Squares for Determination of Dapoxetine Hydrochloride and Tadalafil in Binary Pharmaceutical Mixtures

Abstract

Background: 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. Objective: DAP and TAD were analyzed in their binary mixtures and pharmaceutical formulations using two multivariate calibration chemometric models. Methods: 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. Results: 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. Conclusions: 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.

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

“…On reviewing literature, TMS was quantified by several methods, namely; TLC [16][17][18], HPLC in different matrices [18][19][20][21], capillary electrophoresis [16], spectrophotometry [16,[22][23][24], and electrochemical methods [16,25]. For TAD, several methods were reported for its determination includ-ing TLC [26][27][28][29], HPLC [26,[30][31][32][33][34][35][36], gas chromatography [26,37], capillary electrophoresis [26], spectrophotometry [26,[38][39][40][41], and electrochemical methods [42][43][44].…”

Aplicação de algoritmos de machine learning na área farmacêutica: uma revisão

“…A proposta foi analisar misturas binárias e dosagem farmacêutica e obtiveram sucesso detectando as concentrações de ambas as drogas juntas, tanto na mistura do conjunto de treinamento, como no conjunto de teste. Os resultados obtidos são um incentivo para um desempenho inteligente modelos quimiométricos para a determinação quantitativa de vários medicamentos com equipamentos e dispositivos simples e de baixo custo (Anwar et al, 2020). Research, Society andDevelopment, v. 10, n. 15, e140101522862, 2021 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v10i15.22862 Um levantamento foi feito para analisar o quantitativo de produtos farmacêuticos vendidos durante os anos de 2003 a 20015 no Brasil, e foi usado a regressão linear simples para realizar uma estimativa das vendas para o ano de 2016, por fim, exibir as vendas reais de 2016 e o que foi estimado pela técnica de regressão linear.…”

Simultaneous determination of Avanafil and Dapoxetine in human plasma using liquid chromatography/tandem mass spectrometry (LC-MS/MS) based on a protein precipitation technique

“…These techniques included UV spectrophotometry, 1,2,4-10 spectrouorimetry 6,11-16 and capillary electrophoresis. 17 Various chromatographic methods were also applied for determination of the cited mixture such as HPTLC 4 and HPLC with different detectors as UV, uorescence detection 1,8,9,12,16,[18][19][20] and with tandem mass spectrometry. [21][22][23][24][25][26][27][28] A brief comparison between the different LC-MS/MS methods from the previously reported in the literature and the developed one is elucidated in Table 1.…”