Stability kinetics of fusidic acid: Development and validation of stability indicating analytical method by employing Analytical Quality by Design approach in medicinal product(s)

2019 ◽  
Vol 1120 ◽  
pp. 113-124 ◽  
Author(s):  
Gajanand Sharma ◽  
Kanika Thakur ◽  
Kaisar Raza ◽  
O.P. Katare
Keyword(s):  
Medicinal Product ◽  
Fusidic Acid ◽  
Analytical Method ◽  
Quality By Design ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Quality By Design Approach ◽  
Development And Validation ◽  
Stability Kinetics ◽  
Kinetics Of

Analytical Quality by Design Approach for a Stability-Indicating Method to Determine Apixaban and Its Related Impurities

2019 ◽  
Vol 83 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Jéssica B. Ellwanger ◽  
Nathalie Ribeiro Wingert ◽  
Nadia Maria Volpato ◽  
Cássia Virginia Garcia ◽  
Elfrides E. S. Schapoval ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Related Impurities ◽  
Stability Indicating Method ◽  
Quality By Design Approach

scholarly journals A stability-indicating method for Levetiracetam in tablets using advanced analytical quality-by-design approach ‎

2021 ◽  
Vol 11 (3) ◽  
pp. 126-131
Author(s):  
Maher Abdulrazzaq Al-hakeem ◽  
Lacramioara Popa ◽  
Cristina Dinu-Pirvu ◽  
Mihaela Violeta Ghica ◽  
Razvan Prisada
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Quality By Design Approach

scholarly journals Quality by Design Approach for an Orally Disintegrating Tablet Analytical Method Validation

2018 ◽  
Vol 10 (01) ◽  
Author(s):  
G. Demire ◽  
D. Saray ◽  
B. Yaman, A. Turkyilmaz Yaman ◽  
A. Turkyilmaz
Keyword(s):  
Analytical Method ◽  
Method Development ◽  
Quality By Design ◽  
Hplc Method ◽  
Method Performance ◽  
Analytical Method Validation ◽  
Orally Disintegrating Tablet ◽  
Method Development And Validation ◽  
Quality By Design Approach ◽  
Development And Validation

Quality by Design (QbD) is well established in the pharmaceutical industry for pharmaceutical development and manufacturing processes. The knowledge obtained during development may support the establishment of a design space and determines suitable process controls. This same QbD principle has been applied to the development of analytical methods and is termed “Analytical Quality by Design” (AQbD). Analogous to process QbD, the outcome of AQbD is well understood, fit for purpose, and robust method that consistently delivers the intended performance throughout its life cycle. The present work is aimed to develop an AQbD approach to analytical method development and validation based of Tadalafil and its impurities by the NP-HPLC method. The other objective of this work is to establish an in-depth understanding of the method and build in the quality during the method development to ensure optimum method performance over the lifetime of the product.

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

2020 ◽  
Vol 70 (1) ◽  
pp. 17-33 ◽  
Author(s):  
Chandni Saha ◽  
N. Vishal Gupta ◽  
R. S. Chandan
Keyword(s):  
Flow Rate ◽  
Quality By Design ◽  
Design Approach ◽  
Organic Modifier ◽  
Analytical Quality ◽  
Injection Volume ◽  
Suggested Technique ◽  
Quality By Design Approach ◽  
Atazanavir Sulfate ◽  
Development And Validation

AbstractA 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.

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