Results 11 to 20 of about 833 (196)

AQbD-novel strategy for analytical methods

Future Journal of Pharmaceutical Sciences
Background Analytical Quality by Design (AQbD) has emerged as a pivotal paradigm in the realm of analytical chemistry, revolutionizing the approach to method development and validation. This innovative strategy integrates principles of Quality by Design (
Amruta Bairagi, Rutuja Kothrukar, Hemant Chikhale, Sreya Kosanam, Laxmikant Borse   +4 more
doaj   +2 more sources

Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation. [PDF]

Pharmaceutics, 2023
Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied
Chiarentin L, Cardoso C, Miranda M, Vitorino C.   +3 more
europepmc   +2 more sources

Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

Molecules, 2021
A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form.
Amrit Paudel
exaly   +3 more sources

Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide ¹³¹I Oral Solution. [PDF]

Molecules
The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer ...
Vasquez-Huaman M, Castro-Luna A, Ramos-Cevallos NJ, Ramos-Perfecto D, Alcarraz-Curi M, Segura-Vasquez J, Cáceres-Antaurco D.   +6 more
europepmc   +2 more sources

Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix. [PDF]

BMC Chem
This study presents the development and validation of a fluorescence-based high-performance liquid chromatography (HPLC) method for the quantification of alectinib in rat plasma, with a focus on the application of Analytical Quality by Design (AQbD) to ...
Lee EJ, Koo N, Kim MJ, Lee KR, Chae YJ.
europepmc   +2 more sources

Characterisation of Antisense Oligonucleotides by Ion-Pair Reversed-Phase UHPLC-HRMS: Method development using Design of Experiments. [PDF]

J Mass Spectrom
ABSTRACT The quality control of therapeutic antisense oligonucleotides (ASOs) poses significant analytical challenges due to the complexity of their synthesis and degradation processes and the need to ensure the safety and efficacy of active pharmaceutical ingredients (APIs).
Triolo A, Tavani F, Barnini P, Furlanetto S, Orlandini S.   +4 more
europepmc   +2 more sources

AQbD-Based UPLC-ELSD Method for Quantifying Medium Chain Triglycerides in Labrafac™ WL 1349 for Nanoemulsion Applications. [PDF]

Molecules
In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications.
Gaggero A, Marko V, Jeremic D, Tetyczka C, Caisse P, Afonso Urich JA.   +5 more
europepmc   +2 more sources

Chromatographic study of sitagliptin and ertugliflozin under quality-by-design paradigm [PDF]

Brazilian Journal of Pharmaceutical Sciences, 2023
The present study entails the systematic development and validation of a stability-indicating RP-HPLC method for the analysis of sitagliptin and ertugliflozin in a fixed-dose combination.
Sunitha Gurrala, Shivaraj , Panikumar Durga Anumolu, Haripriya D, Subrahmanyam CVS   +4 more
doaj   +3 more sources

AQbD-driven development of a green RP-HPLC method for nirogacestat with LC-MS structural elucidation. [PDF]

BMC Chem
Nirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling.
Sabi J, Kannaiah KP, Chanduluru HK, Nakka S, Elagamy SH, Obaydo RH.   +5 more
europepmc   +2 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 Chem
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 ...
Vanga MG, Bukke SPN, Kusuma PK, Narapureddy BR, Thalluri C.   +4 more
europepmc   +2 more sources