Results 1 to 10 of about 1,038 (200)

Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel [PDF]

Pharmaceutics, 2022
The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel.
Réka Szoleczky, Mária Budai-Szűcs, Erzsébet Csányi, Szilvia Berkó, Péter Tonka-Nagy, Ildikó Csóka, Anita Kovács   +6 more
doaj   +15 more sources

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants [PDF]

Plants, 2022
Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery.
Geonha Park, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, Young Pyo Jang   +4 more
doaj   +7 more sources

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

Journal of Pharmaceutical and Biomedical Analysis, 2022
Analytical procedure development for quantifying 10 impurities in Tenofovir Alafenamide Fumarate (TAF) tablets was a challenge for analytical and formulation researchers. The aim of this paper was to develop a robust, regulatory-flexible, application-specific Ultra Performance Liquid Chromatography (UPLC) analytical procedure using the Analytical ...
Jianhao, Teng, Chunmei, Zhu, Jinyuan, Lyu, Linyu, Pan, Meng, Zhang, Fuli, Zhang, Haoxiang, Wu   +6 more
semanticscholar   +5 more sources

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach. [PDF]

J Chromatogr Sci, 2016
The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf ...
Khurana RK, Rao S, Beg S, Katare OP, Singh B.   +4 more
europepmc   +5 more sources

Analytical quality by design (AQbD) based optimization of RP-UPLC method for determination of nivolumab and relatlimab in bulk and pharmaceutical dosage forms

Future Journal of Pharmaceutical Sciences
Background The Analytical Quality by Design (AQbD) methodology extends the application of Quality by Design (QbD) principles to the management of the analytical procedure life cycle, encompassing method creation, optimization, validation, and continuous ...
Mohana Vamsi Nuli, Ramanjaneyulu Seemaladinne, Anil Kumar Tallam   +2 more
doaj   +3 more sources

Integrating green analytical chemistry and analytical quality by design: an innovative approach for RP-UPLC method development of ensifentrine in bulk and inhalation formulations [PDF]

BMC Chemistry
Background Chronic obstructive pulmonary disease (COPD) is a significant global health issue, worsened by pollution and modernisation. Ensifentrine (EFT), a new dual inhibitor of phosphodiesterase PDE3 and PDE4, is being developed for inhalation to ...
Mohan Goud Vanga, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Bayapa Reddy Narapureddy, Chandrashekar Thalluri   +4 more
doaj   +3 more sources

Analytical quality by design (AQbD) assisted RP-HPLC technique for quantification of Picroside II in bulk and pharmaceutical dosage form

Future Journal of Pharmaceutical Sciences
Background Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the ...
Sharib Raza Khan, Shailesh Dadge, Shivam Rathaur, Jiaur R. Gayen   +3 more
doaj   +4 more sources

Analytical Quality by Design (AQbD)-oriented RP-UFLC method for quantification of lansoprazole with superior method robustness

Journal of Liquid Chromatography & Related Technologies, 2017
A reversed-phase ultrafast liquid chromatography method was developed for quantification of lansoprazole in pharmaceutical dosage form using analytical quality by design approach. Systematic planning and experimentation using design of experiment approach were used for method development and optimization studies. A central composite design was used for
Panda, Sagar Suman, Venkata Varaha Ravi Kumar Bera, Sarwar Beg, Omkar Mandal   +3 more
semanticscholar   +4 more sources

New Trends in the Quality Control of Enantiomeric Drugs: Quality by Design-Compliant Development of Chiral Capillary Electrophoresis Methods [PDF]

Molecules, 2022
Capillary electrophoresis (CE) is a potent method for analyzing chiral substances and is commonly used in the enantioseparation and chiral purity control of pharmaceuticals from different matrices.
Serena Orlandini, Gabriel Hancu, Zoltán-István Szabó, Adriana Modroiu, Lajos-Attila Papp, Roberto Gotti, Sandra Furlanetto   +6 more
doaj   +3 more sources

Integrated Analytical Quality by Design (AQbD) Approach for the Development and Validation of Bioanalytical Liquid Chromatography Method for Estimation of Valsartan [PDF]

Journal of Chromatographic Science, 2020
Abstract The present studies describe the systematic development and validation of a simple, rapid, sensitive and cost-effective reversed-phase high-performance liquid chromatographic bioanalytical method for the estimation of valsartan in rat plasma employing analytical quality by design (AQbD) principles quality risk management was ...
Shantanu, Bandopadhyay, Sarwar, Beg, O P, Katare, Teenu, Sharma, Bhupinder, Singh   +4 more
openaire   +3 more sources