Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design

Yabré, Moussa; Ferey, Ludivine; Somé, Touridomon Issa; Sivadier, Guilhem; Gaudin, Karen

doi:10.1016/j.jpba.2020.113507

Cited by 30 publications

(15 citation statements)

References 25 publications

(47 reference statements)

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“…In the process of developing new drugs, the AQbD approaches have been applied in several stages, such as raw material control [ 94 ], bioassay [ 95 , 96 ], stability test [ 96 , 97 ], impurity test [ 98 , 99 , 100 ], efficacy and safety test [ 101 ]. However, there are several limits to apply the AQbD approach in developing new drugs based on medicinal plants, and this is closely related to the limitations of botanical resources as a raw material for drug development [ 1 ].…”

Section: Perspectives : Challenges and Prospectsmentioning

confidence: 99%

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Park

Kim

et al. 2022

Plants

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Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method operable design region (MODR), and lowers the out-of-specification (OOS) results. However, it is difficult to follow all the AQbD workflow steps in the field of medicinal plants analysis, such as defining the analytical target profiles (ATPs), identifying critical analytical procedure parameters (CAPPs), among others, because the complexity of chemical and biological properties in medicinal plants acts as a barrier. In this review, various applications of AQbD to medicinal plant analytical procedures are discussed. Unlike the analysis of a single compound, medicinal plant analysis is characterized by analyzing multiple components contained in biological materials, so it will be summarized by focusing on the following points: Analytical methods showing correlations within analysis parameters for the specific medicinal plant analysis, plant raw material diversity, one or more analysis targets defined for multiple phytochemicals, key analysis attributes, and analysis control strategies. In addition, the opportunities available through the use of design-based quality management techniques and the challenges that coexist are also discussed.

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Section: Perspectives : Challenges and Prospectsmentioning

confidence: 99%

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Park

Kim

et al. 2022

Plants

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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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“…Contour plots and response surface plots are graphical representations of the mathematical model that best fit the data. These graphs show how the response changes depending on the factors values and are used to find the optimal conditions for a HPLC separation (21)(22)(23). However, it is often the case that more than two factors are statistically significant.…”

Section: ) Analyze the Data Obtained By The Analytical Proceduresmentioning

confidence: 99%

“…Literature survey revealed tremendous number of HPLC methods that were developed using DoE-based AQbD approach in recent years (23,62,69,(71)(72)(73). In most studies, CCD and D-optimal designs were favorably used to optimize HPLC systems with 2 critical method parameters (CMPs) and BBD in case of 3 or 4 CMPs.…”

Section: Regulatory Aspects Related To Doe In Hplc Analysismentioning

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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Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design

Cited by 30 publications

References 25 publications

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants

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

Experimental design in HPLC separation of pharmaceuticals

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