scholarly journals Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

2019 ◽  
Vol 65 (2) ◽  
pp. 37-44 ◽  
Author(s):  
Maher Abdulrazzaq Alhakeem ◽  
Mihaela Violeta Ghica ◽  
Cristina Dinu Pîrvu ◽  
Valentina Anuța ◽  
Lăcrămioara Popa
Keyword(s):  
Risk Assessment ◽  
Analytical Method ◽  
Method Development ◽  
Quality By Design ◽  
Control Process ◽  
Analytical Techniques ◽  
Analytical Quality ◽  
Comprehensive Knowledge ◽  
Development Concept ◽  
Target Profile

AbstractQuality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the AQbD. Inside the method operable design region (MODR), the AQbD permits the movements of the analytical methods. This paper has been produced to discuss various views of analytical scientists, the comparison with conventional methods, and the phases of the analytical techniques.

scholarly journals Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Ramalingam Peraman ◽  
Kalva Bhadraya ◽  
Yiragamreddy Padmanabha Reddy
Keyword(s):  
Analytical Method ◽  
Method Development ◽  
Quality By Design ◽  
Current Trend ◽  
Quality System ◽  
Analytical Quality ◽  
Pharmaceutical Quality ◽  
Pharmaceutical Quality System ◽  
Methods Analytical ◽  
Regulatory Flexibility

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

scholarly journals Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method

RSC Advances ◽  
2021 ◽  
Vol 11 (45) ◽  
pp. 27820-27831
Author(s):  
Hemanth Kumar Chanduluru ◽  
Abimanyu Sugumaran
Keyword(s):  
Isosorbide Dinitrate ◽  
Method Development ◽  
Quality By Design ◽  
Environmentally Benign ◽  
Analytical Quality ◽  
Stepping Stone ◽  
Hydralazine Hydrochloride

Analysing isosorbide dinitrate and hydralazine by using an eco-friendly method is an initial stepping stone towards environmentally benign method development, and its combination with the AQbD makes it the method to use for ages without revalidation.

scholarly journals Quality-by-Design Is a Tool for Quality Assurance in the Assessment of Enantioseparation of a Model Active Pharmaceutical Ingredient

2020 ◽  
Vol 13 (11) ◽  
pp. 364
Author(s):  
Dina Aboushady ◽  
Maria Kristina Parr ◽  
Rasha S. Hanafi
Keyword(s):  
Quality Assurance ◽  
Analytical Method ◽  
Mobile Phase ◽  
Method Development ◽  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Binding Interaction ◽  
Mobile Phase Additives ◽  
Central Composite Designs ◽  
Chiral Mobile Phase Additives

The design of experiments (DoE) is one of the quality-by-design tools valued in analytical method development, not only for cost reduction and time effectiveness, but also for enabling analytical method control and understanding via a systematic workflow, leading to analytical methods with built-in quality. This work aimed at using DoE to enhance method understanding for a developed UHPLC enantioseparation of terbutaline (TER), a model chiral drug, and to define quality assurance parameters associated with using chiral mobile phase additives (CMPA). Within a response surface methodology workflow, the effect of different factors on both chiral resolution and retention was screened and optimized using Plackett-Burman and central composite designs, respectively, followed by multivariate mathematical modeling. This study was able to delimit method robustness and elucidate enantiorecognition mechanisms involved in interactions of TER with the chiral modifiers. Among many CMPAs, successful TER enantioresolution was achieved using hydroxypropyl β-cyclodextrin (HP-β-CD) added to the mobile phase as 5.4 mM HP-β-CD in 52.25 mM ammonium acetate. Yet, limited method robustness was observed upon switching between the different tested CMPA, concluding that quality can only be assured with specific minimal pre-run conditioning time with the CMPA, namely 16-column volume (60 min at 0.1 mL/min). For enantiorecognition understanding, computational molecular modeling revealed hydrogen bonding as the main binding interaction, in addition to dipole-dipole inside the CD cavity for the R enantiomer, while the S enantiomer was less interactive.

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