A combined approach of green chemistry and Quality-by-Design for sustainable and robust analysis of two newly introduced pharmaceutical formulations treating benign prostate hyperplasia

Abdel-Moety, Ezzat M.; Rezk, Mamdouh R.; Wadie, Mina; Tantawy, Mahmoud A.

doi:10.1016/j.microc.2020.105711

Cited by 59 publications

(18 citation statements)

References 37 publications

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“…Currently, green analytical chemistry involves the application of pharmaceutical analysis. The greenness of the proposed methods was achieved by applying 3Rs philosophy (replace, reduce and re-use) [ 40 ]. Reducing energy or heat usage and replacing organic solvents with distilled water, either by making the stock of the drug or completing the calibration's flasks, helped in obtaining a higher score in the analytical ecoscale.…”

Section: Resultsmentioning

confidence: 99%

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Factorial design-assisted spectroscopic determination of oxybutynin hydrochloride

et al. 2021

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In this study, we have developed two facile spectroscopic methods for quantifying oxybutynin (OBT) hydrochloride in its pure form and tablets using design of experiments (DOEs). The spectroscopic methods depended on the ion-pair complex formation between the tertiary amino group in the drug and eosin in 0.2 M acetate buffer of pH 4. Method I involves spectrophotometric measurement of the absorbance of the developed complex at 550 nm and showed linearity through 1.0–10.0 µg ml −1 . Method II involves spectrofluorometric measurement of the quenching influence of OBT on the native fluorescence of eosin (λ excitation/λ emission of 304/548 nm) and showed linearity through 1.0–6.0 µg ml −1 . Critical parameters were identified through preliminary trials and optimized using the DOE. Additionally, the quenching mechanism was investigated and the pathway of the reaction was postulated. The fluorescence quenching constant and thermodynamic parameters were explored using the Stern–Volmer plot and Van't Hoff graph, respectively. Assessments conducted via analytical ecoscale revealed the ‘excellent-greenness’ of the methodology. The two methods have the potentials of being green and fast compared with other reported methods.

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Section: Resultsmentioning

confidence: 99%

Section: Greenness Evaluationmentioning

confidence: 99%

Factorial design-assisted spectroscopic determination of oxybutynin hydrochloride

et al. 2021

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“…In recent years, the application of DoE in LC has greatly improved the efficiency of analytical method development [74]. Some examples of DoE applied in LC are listed in Table 3 [75][76][77][78][79][80][81][82][83][84].…”

Section: Liquid Chromatography (Lc)mentioning

confidence: 99%

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

et al. 2022

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Design of experiment (DoE) techniques have been widely used in the field of chromatographic parameters optimization as a valuable tool. A systematic literature review of the available DoE techniques applied to the development of a chromatographic analysis method is presented in this paper. First, the most common available designs and the implementation steps of DoE are comprehensively introduced. Then the studies in recent 10 years for the application of DoE techniques in various chromatographic techniques are discussed, such as capillary electrophoresis, liquid chromatography, gas chromatography, thin‐layer chromatography, and high‐speed countercurrent chromatography. Current problems and future outlooks are finally given to provide a certain inspiration of research in the application of DoE techniques to the different chromatographic techniques field. This review contributes to a better understanding of the DoE techniques for the efficient optimization of chromatographic analysis conditions, especially for the analysis of complex systems, such as multicomponent drugs and natural products.

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“…Commonly, 6-8 factors are assessed using PBD (34)(35)(36)(37)(38). In latest publications, PBD has been employed in the robustness testing of AQbD-supported LC methods (39) or as a screening tool (40)(41)(42).…”

Section: Plackett-burman Designmentioning

confidence: 99%

Experimental design in HPLC separation of pharmaceuticals

Stojanović¹,

Krmar²,

Protić³

et al. 2021

Arhiv za farmaciju

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Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background of the DOE and provides step-by-step instruction for its implementation in HPLC pharmaceutical practice. It particularly discusses the classification of various design types and their possibilities to rationalize the different stages of HPLC method development workflow, such as the selection of the most influential factors, factors optimization and assessment of the method robustness. Additionally, the application of the DOE-based Analytical Quality by Design (AQbD) concept in the LC method development has been summarized. Recent achievements in the use of DOE in the development of stability-indicating LC and hyphenated LC-MS methods have also been briefly reported. Performing of Quantitative structure retention relationship (QSRR) study enhanced with DOE-based data collection was recomended as a future perspective in description of retention in HPLC system.

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A combined approach of green chemistry and Quality-by-Design for sustainable and robust analysis of two newly introduced pharmaceutical formulations treating benign prostate hyperplasia

Cited by 59 publications

References 37 publications

Factorial design-assisted spectroscopic determination of oxybutynin hydrochloride

Factorial design-assisted spectroscopic determination of oxybutynin hydrochloride

Design of experiment techniques for the optimization of chromatographic analysis conditions: A review

Experimental design in HPLC separation of pharmaceuticals

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