Results 21 to 30 of about 459 (187)

Software-assisted analytical Quality by Design for stability-indicating method development: integration of DoE and predictive retention modeling using MODDE® and DryLab® [PDF]

Makedonsko Farmacevtski Bilten
In modern pharmaceutical development, the increasing complexity of drug substances, formulations, and regulatory expectations has rendered traditional one-factor-at-a-time (OFAT) approaches to analytical method development inefficient and increasingly ...
Dino Karpicarov, Ivana Mitrevska, Blagica Manchevska, Paulina Apostolova, Jasmina Tonic Ribarska, Biljana Gjorgjeska   +5 more
doaj   +4 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   +2 more sources

Development of a green chemistry based bioanalytical method using response surface methodology to analyze febuxostat and indomethacin in rabbit plasma [PDF]

Scientific Reports
This research established an environmentally friendly and sustainable approach to measure Febuxostat and Indomethacin levels in rabbit plasma samples, utilizing isocratic liquid chromatography guided by green analytical chemistry principles and ...
Akramul Ansary, Piyongsola, Biprojit Paul, Koushik Nandan Dutta, Bhargab Jyoti Sahariah, Manoj Kumar Deka, Amit kumar Das, Manish Majumder   +7 more
doaj   +2 more sources

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

Journal of Liquid Chromatography and 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
Sagar Suman Panda, Sarwar Beg
exaly   +2 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   +2 more sources

Analytical quality by design (AQbD) approach for the simultaneous quantification of FDC in a cardiovascular drug by RP-HPLC method

Future Journal of Pharmaceutical Sciences
Background A sustainable and stability-indicating reversed-phase high-pressure liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of chlorthalidone (CHL), Amlodipine (AML), and olmesartan medoxomil (OLM) in a ...
Varsha Thorat, Sudhakar Alave, Vijay Bagul   +2 more
doaj   +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

Quality by Design: Approach to Analytical Method Validation [PDF]

, 2022
A pharmaceutical industry is highly regulated by a quality policy in its management. The principles of Quality by Design (QbD) must be applied to ensure the development of pragmatic and systematic methods while managing the risks associated with ...
Chaerunisaa, Anis Yohana, Arifka, Mia, Pratama, Reza, Dewi, Mayang Kusuma   +3 more
core   +2 more sources

Approach of analytical quality by design and regulatory need [PDF]

, 2022
This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. Quality cannot be tested into products but quality should be built in by design. The concept of QbD can be
Mahapatra, Asmita, Meyyanathan, S. N.
core   +2 more sources

Analytical Quality by Design-Guided Optimisation and Validation of a Short-Run Stability-Indicating Reverse-Phase Ultra-Fast Liquid Chromatography (RP-UFLC) Method for the Quantitation of Nonivamide. [PDF]

Biomed Chromatogr
ABSTRACT Nonivamide (NON), a capsaicin analogue with similar pharmacological effects, is used in pain management, yet limited information exists on its accurate quantification by reverse‐phase liquid chromatography. A cost‐effective, efficient and precise RP‐HPLC method was developed, optimised using response surface methodology (central composite ...
Mahlangu P, Poka MS, Makoni PA, Witika BA.   +3 more
europepmc   +2 more sources