Risk-based approach for method development in pharmaceutical quality control context: A critical review

Deidda, Riccardo; Orlandini, Serena; Hubert, Philippe; Hubert, Cédric

doi:10.1016/j.jpba.2018.07.050

Cited by 96 publications

(94 citation statements)

References 55 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The DoE based approach for the development of the HPTLC method has several advantages like interaction among the factors can be estimated and experimental design space can be defined for repeatable results. Box‐Behnken design used in present study consist of seventeen runs including five center runs, which help to know the experimental error .…”

Section: Resultsmentioning

confidence: 99%

“…To study and understand the effect of the independent variables, their interaction effects and design's flexibility, a Box–Behnken design consisting of three factors at three levels with 17 runs including five center points was selected for optimization of quantitative HPTLC method for Retapamulin . Based on preliminary trials, selected chromatographic factors and their levels are shown in Table .…”

Section: Methodsmentioning

confidence: 99%

“…Considering this fact, the International Council for Harmonisation of technical requirements for pharmaceuticals for human use (ICH) and Food and Drug Administration (FDA) have recently demanded systematic approach in development of analytical method using Design of Experiment (DoE) to ensure robust analytical method performance. DoE helps to understand the quantitative effect of individual factor as well as inter‐relationship between factors and screen a large number of factors to identify important ones to develop robust analytical method .…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Design, development and optimization of new high performance thin‐layer chromatography method for quantitation of Retapamulin in pharmaceutical formulation: Application of design of experiment

Patel

2020

Separation Science Plus

View full text Add to dashboard Cite

The objective of the present study was to design, develop and optimize Design of Experiments supported high performance thin-layer chromatography method for quantitative estimation of Retapamulin in marketed cream and microemulsion formulations. Design of Experiments help to identify and understand the effect of important factors on response with minimum experimental run in developing robust method. To optimize chromatographic conditions and to study their effects on separation of Retapamulin, Box-Behnken experimental design was selected. Experimental conditions with desirability 1 were selected which gave the optimal composition of methanol in mobile phase along with ethyl acetate: ammonia, development distance of 70 millimeter and chamber saturation time of 22 minutes. Retapamulin was well separated with retardation factor value 0.60 from excipients of marketed cream formulation on high performance thin-layer chromatography plate using optimized chromatographic conditions. The optimized method was validated and statistical analysis proved that the method is specific, sensitive, accurate and precise. A new high performance thin-layer chromatography has been successfully designed, developed, optimized and validated for quantification of Retapamulin in cream formulation using Box-Behnken design.The proposed high performance thin-layer chromatography method is easy, convenient, reliable and accurate for the routine analysis of Retapamulin in marketed cream and microemulsion formulations.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Design, development and optimization of new high performance thin‐layer chromatography method for quantitation of Retapamulin in pharmaceutical formulation: Application of design of experiment

Patel

2020

Separation Science Plus

View full text Add to dashboard Cite

show abstract

“…This approach applies total error to evaluate the risk of measurement failure. The β-expectation tolerance limits are calculated for each concentration level and 95% of the measurements should fall within the acceptance limits [50]. The acceptance limit, λ (Equation 9), is the difference between the predicted API concentration by the model y i and the true value (y i,t ), and was set to 5% for API determination [43,47,51].…”

Section: Accuracy Profilementioning

confidence: 99%

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

et al. 2020

View full text Add to dashboard Cite

A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established for the development of drug products/substances can equally be applied to the development of analytical procedures. This paper presents the development and validation of a quantitative method to predict the concentration of piroxicam in Kollidon® VA 64 during hot melt extrusion using analytical quality by design principles. An analytical target profile was established for the piroxicam content and a novel in-line analytical procedure was developed using predictive models based on UV-Vis absorbance spectra collected during hot melt extrusion. Risks that impact the ability of the analytical procedure to measure piroxicam consistently were assessed using failure mode and effect analysis. The critical analytical attributes measured were colour (L* lightness, b* yellow to blue colour parameters—in-process critical quality attributes) that are linked to the ability to measure the API content and transmittance. The method validation was based on the accuracy profile strategy and ICH Q2(R1) validation criteria. The accuracy profile obtained with two validation sets showed that the 95% β-expectation tolerance limits for all piroxicam concentration levels analysed were within the combined trueness and precision acceptance limits set at ±5%. The method robustness was tested by evaluating the effects of screw speed (150–250 rpm) and feed rate (5–9 g/min) on piroxicam content around 15% w/w. In-line UV-Vis spectroscopy was shown to be a robust and practical PAT tool for monitoring the piroxicam content, a critical quality attribute in a pharmaceutical HME process.

show abstract

“…This component is the establishment of reliable methods intended to be used in analytical chemistry laboratories; 4. Control strategy and validation are conducted via observation of several analytical figures of merit, such as accuracy and precision expressed as relative standard deviation (RSD) and coefficient of determination (R 2 ), among others [1][2][3][4].…”

Section: Introductionmentioning

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

Risk-based approach for method development in pharmaceutical quality control context: A critical review

Cited by 96 publications

References 55 publications

Design, development and optimization of new high performance thin‐layer chromatography method for quantitation of Retapamulin in pharmaceutical formulation: Application of design of experiment

Design, development and optimization of new high performance thin‐layer chromatography method for quantitation of Retapamulin in pharmaceutical formulation: Application of design of experiment

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

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

Contact Info

Product

Resources

About