Analytical quality-by-design (AQbD) guided development of a robust HPLC method for the quantification of plumbagin from <i>Plumbago</i> species

Tiwari, Ritu; Kumar, Amit; Solanki, Pavitra; Dhobi, Mahaveer; Sundaresan, Velusamy; Kalaiselvan, Vivekanandan; Raghuvanshi, Rajeev Singh

doi:10.1080/10826076.2021.1973027

Cited by 9 publications

(14 citation statements)

References 22 publications

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“…This technique focused on obtaining chromatograms rather than obtaining the spectra of APIs to analyze the desired APIs in the oceans of various phytochemicals. Classes of flavonoids [ 34 , 35 ], terpenoids [ 36 ], quinones [ 37 ], saponins [ 38 , 39 ], and phenolic compounds, such as curcuminoids [ 40 ] and coumarins [ 36 ] were analyzed by (Ultra) High Performance Liquid Chromatography-Ultraviolet/Visible (photodiode array detector) ((U)HPLC-UV/Vis (PDA) techniques. Mass spectrometry was employed for the analysis of terpene lactones [ 41 ] and polyphenols [ 42 ], and supercritical fluid chromatography was utilized for the analysis of cannabinoids [ 43 ].…”

Section: Fit-for-purpose : Analytical Target Profiles (Atps)mentioning

confidence: 99%

“…It can dissect the risk in various categories related, for example, to sample preparation, instrumentation, materials, personnel factors, and environmental conditions in order to determine the root causes of the problem. For the most of chromatographic methods, risk assessment is performed using the Ishikawa diagram with 6M branches (Mother nature, Machine, Materials, Method, Measurement, and Man) [ 34 , 37 , 41 , 42 , 43 , 44 , 46 ]. This method allows us to visualize and simultaneously show various parameters that have the potential to influence the analysis results, however it is not able to determine the association between parameters.…”

Section: Backbone-of-aqbd : Risk Assessmentmentioning

confidence: 99%

“…It has the advantage of being able to grasp the effect of each parameter on each CAPAs at a glance. Tiwari et al [ 37 ] and Kim et al [ 36 ] used the risk estimation matrix to estimate the correlation between CAPAs and latent CAPPs in the HPLC analysis. When CAPPs are determined without risk assessment based on prior knowledge and prior studies, a few preliminary experiments need to be conducted to test the effectiveness of CAPPs [ 47 ].…”

Section: Backbone-of-aqbd : Risk Assessmentmentioning

confidence: 99%

“…The asymmetrical designs, such as D-optimal design, are applied when it is necessary to evaluate an asymmetrical experimental area [ 53 , 62 ]. To optimize the analytical procedure for natural products, 3 3 -level FFD [ 40 , 43 , 44 , 46 ], CCD [ 34 , 35 , 36 , 39 ], BBD [ 37 , 41 , 45 , 47 , 49 ], and Doehlert design [ 42 , 48 ] are mainly conducted. The characteristics of the optimization DoE models are summarized in Table 3 , and four commonly used optimization models are described in detail.…”

Section: Make-the Best Conditions : Design Of Experiments (D...mentioning

confidence: 99%

“…Conversely, they cannot be applied to situations where we want to know the extreme response, i.e., in the vertices of the cube [ 76 ]. The matrix of the BBD for three factors is summarized in Table 7 and Figure 4 c. For the optimization of parameter conditions for the analysis of medicinal plants, BBD is one of the frequently applied designs [ 37 , 41 , 45 , 47 , 49 ]. Zhang et al [ 41 ] and Tiwari et al [ 37 ] examined the relationship between CAPAs and CAPPs to optimize the conditions of analytical parameters for HPLC separations through BBD experimental data.…”

Section: Make-the Best Conditions : Design Of Experiments (D...mentioning

confidence: 99%

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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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