Application of quality by design (QbD) to the development and validation of analytical methods

Lloyd, David K.; Bergum, James

doi:10.1016/b978-0-08-098350-9.00003-5

Cited by 11 publications

(13 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Further, FMEA aids to rank and prioritize these factors into low, medium, and high risks based on a composite score called the risk priority number (RPN). The RPN is calculated based on the impact of risk on the method, frequency of occurrence and the ability to detect the failure (impact * occurrence * detectability) (14).…”

Section: Risk Assessment Studiesmentioning

confidence: 99%

“…Overcoming the challenges of one factor at a time (OFAT), the QbD approach has amended the pharmaceutical quality management system (14). QbD systematically builds quality within the process, eliminating quality testing at the end of the process (15).…”

mentioning

confidence: 99%

“…The paradigm advances by identifying the critical process and material parameters through sound risk assessment studies (16), further through the concept of experimental designs/design of experiments (DOE); as a result, the multifactor effects on selected responses are observed. DOE also reduces the number of experiments to be performed when a large number of factors (inputs) are involved (14). The concept of QbD has been present in various industries since the 1970s but was introduced into the pharmaceutical industry in 2004 through Pharmaceutical cGMPs for the 21st Century initiative (17); it is also reflected in ICH Q8-Q10 guidelines (18)(19)(20).…”

mentioning

confidence: 99%

See 2 more Smart Citations

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

Section: Risk Assessment Studiesmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

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

show abstract

“…For AQbD approach, Ishikawa diagram was used to study the relationship between variable input parameters and the method performance characteristics of the spectrophotometric analytical methods [8] ( fig. 2).…”

Section: Implementation Of Aqbd Approach In the Development Of The Anmentioning

confidence: 99%

“…In a similar manner for analytical methods, QbD approach involves a full understanding of how the analytical technique attributes and operating conditions affect the analytical performance. Factors to study in" analytical quality by design" (AQbD) approach may include the type of analytical technique chosen, reagents used, and instrumental parameters [8].…”

Section: Introductionmentioning

confidence: 99%

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH

et al. 2018

View full text Add to dashboard Cite

Objective: To develop a simple, rapid, accurate, robust and inexpensive spectrophotometric method for the estimation of benidipine hydrochloride by using quality by design (QbD)” approach.Methods: A UV spectrophotometric method was developed on Shimadzu UV-1800 double beam spectrophotometer using methanol as solvent and wavelength of 236 nm was selected as absorbance maxima (𝜆max). Effect of input variables on spectrum characteristics were studied for the selection of critical parameters and proposed method was validated for various parameters like system suitability, linearity, precision, accuracy, detection limits and quantification limits as per the International Conference on Harmonization guidelines ICH Q2(R1).Results: Linearity of the method was found to be excellent over the concentration range 3 to 18 µg/ml with high correlation coefficient value of 0.9999. Limits of detection and quantification were found to be 0.20 µg/ml and 0.60 µg/ml respectively. The mean recovery was found to be 100.35 % with low percentage relative standard deviation (% RSD) value. The precision study also has shown low % RSD value (<1). No interfering peaks were observed during specificity studies.Conclusion: Obtained result indicated that the developed spectrophotometric method is robust and efficient for the determination of benidipine hydrochloride.

show abstract

Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity

Corredor

Lozano

et al. 2014

J Pharm Innov

View full text Add to dashboard Cite

Application of quality by design (QbD) to the development and validation of analytical methods

Cited by 11 publications

References 10 publications

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

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

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH

Analytical Method Quality by Design for an On-Line Near-Infrared Method to Monitor Blend Potency and Uniformity

Contact Info

Product

Resources

About