‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances

Dispas, Amandine; Avohou, Hermane T.; Lebrun, Philippe; Hubert, Philippe; Hubert, Cédric

doi:10.1016/j.trac.2017.10.028

Cited by 87 publications

(44 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Since AQbD compliant analytical methods focus on separation, resolution, and retention, i.e. qualitative CMAs [19], the robustness of quantitative performances (i.e. peak area of investigated substances) should be studied as a part of method validation.…”

Section: Resultsmentioning

confidence: 99%

“…[17]. Thus, the aim of this research was to develop reliable and robust chaotropic chromatography method for the determination of aripiprazole and its four impurities in tablets (Figure 1) supported by Analytical Quality‐by‐Design (AQbD) approach whose superiority over conventional approaches, like multicriteria decision making approach with grid point search, is already confirmed [18–20].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

Rmandić

Malenović

2020

J of Separation Science

View full text Add to dashboard Cite

In this paper, development of robust and reliable chaotropic chromatography method for the determination of aripiprazole and its impurities, following Analytical Quality by Design principles is presented. The efficient baseline separation and accurate determination of aripiprazole and its four impurities from tablets were set as Analytical Target Profile. In line with it, the influence of Critical Method Parameters (acetonitrile content, concentration of perchloric acid in water phase, and column temperature) on predefined Critical Method Attributes (separation of the critical pair of peaks, retention of the first and last eluting peak) was investigated with aid of the Central Composite Design. Further on Design Space, where Critical Method Parameters meet predefined acceptance limits with a high level of probability (π ≥ 85%), was computed as a result of performed Monte Carlo simulations. A normal operating conditions corresponding to 34% of acetonitrile, 66% of 42.5 mM perchloric acid, and column temperature at 35°C were selected from created Design Space. Robustness testing of the quantitative performances of the developed method was conducted combining Plackett–Burman design with alias matrix approach. Through the additional validation testing, reliability of the developed method for the use in the routine practice was completely confirmed.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

Rmandić

Malenović

2020

J of Separation Science

View full text Add to dashboard Cite

show abstract

“…The first step in the AQbD approach is to define the objectives of the method, collectively termed as analytical target profile (ATP)/quality target method profile (QTMP) (22)(23)(24). The ATP of the current method was to develop a simple, accurate, precise, robust and specific method meeting the critical quality attributes (CQAs).…”

Section: Methods Development Using the Aqbd Approachmentioning

confidence: 99%

Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach

2019

View full text Add to dashboard Cite

A UPLC-MS method for the estimation of atazanavir sulfate was developed using the "analytical quality by design" approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of organic modifier, flow rate and injection volume. Optimization performed using Box-Behnken Design (BBD) established 10 % organic modifier, 0.4 mL min -1 flow rate and 6-µL injection volume as the optimum method conditions. Atazanavir sulfate eluted at 5.19 min without any interference. Method validation followed international guidelines. The method has proven linearity in the range of 10-90 µg mL -1 . Recovery was between 100.2-101.0 % and precision within the accepted limits (RSD 0.2-0.7 %). LOD and LOQ were 2.68 and 8.14 µg mL -1 , resp. Stress testing stability studies showed atazanavir sulfate to degrade under acidic and basic conditions. The suggested technique is simple, rapid and sustainable. It is, therefore, suggested for routine analysis of atazanavir sulfate.

show abstract

“…In 2018, Dispas et al [39] discussed the importance of QbD strategy for analyzing drug impurities. They mentioned that QbD facilitates quality risk management and provides ways to identify and control potential quality issues during both product development and manufacturing.…”

Section: Quality By Design (Qbd) Design Of Space and Design Of Expermentioning

confidence: 99%

Key information related to quality by design (QbD) applications in analytical methods development

Araujo¹,

Andrade²,

Babos³

et al. 2020

Braz. J. Anal. Chem.

View full text Add to dashboard Cite

In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production.

show abstract

‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances

Cited by 87 publications

References 35 publications

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach

Key information related to quality by design (QbD) applications in analytical methods development

Contact Info

Product

Resources

About