Results 81 to 90 of about 459 (187)

Development of LC/LCMS method for estimation of impurities in anti-HIV drug (Bictegravir) using Analytical Quality by Design (AQbD) approach

Chinese Journal of Analytical Chemistry
Rambabu Gundla, Naresh Kumar Katari, Sreekantha B Jonnalagadda   +2 more
exaly   +2 more sources

Desenvolvimento e otimização de método analítico por Analytical Quality by Design (AQbD) para determinação de teor do produto acabado Succinato de Solifenacina [PDF]

, 2021
O Guia Q14 do ICH surge com o propósito de revisar o guia Q2 (R1) e complementar os guias Q8(R2) a Q12, visando adotar os princípios do QbD (Quality by Design) e aplicar no desenvolvimento e validação de métodos analíticos, denominado AQbD (Analytical ...
Diego, Giovanna Cristina Marcelino [UNIFESP]
core  

AQbD enabled optimization of RP-HPLC method for the estimation of pioglitazone and vildagliptin and its forced degradation studies

Journal of Applied Pharmaceutical Research
Background: Diabetes mellitus is a metabolic disorder that is managed with combination therapy. Pioglitazone improves insulin sensitivity by activating PPAR-γ, whereas vildagliptin increases incretin activity by inhibiting DPP-4.
P V Devi Swapna, G. Saravanan
doaj   +1 more source

Analytical Quality by Design (AQbD) of the TLCScanner Method for the Determination of Radiochemical Purity of the Radiopharmaceutical Sodium Iodide 131I Oral Solution

, 2023
The objective of the study was to apply the principles of analytical quality by design (AQbD) to the analytical method for the determination of the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, by means of thin layer chromatography (TLC) with a Radio-TLC scanner, the same one that allows to evaluate the quality
Miguel Vasquez, Américo Castro-Luna, Norma Julia Ramos-Cevallos, Donald Ramos-Perfecto, Mario Alcarraz-Curi, Jacqueline Segura-Vasquez, Danny Cáceres-Antaurco   +6 more
openaire   +1 more source

Isolation, Identification, and Characterization of Forced Degradation Products of Bosentan by Using Advanced Analytical Techniques

SEPARATION SCIENCE PLUS, Volume 7, Issue 10, October 2024.
ABSTRACT The present study explains the degradation behavior of bosentan (BOS), active pharmaceutical ingredient (API) (BOS monohydrate), a Food and Drug Administration (FDA)–approved drug used for the treatment of chronic heart failure, subarachnoid hemorrhage, and Raynaud's syndrome pulmonary hypertension. The stress study was performed under various
Rajesh Kanagaddi, Satya Sree Nannapaneni, Jayaprakash Kanijam Raghupathi, Naresh Kumar Katari, Suresh Salakolusu, J. N. S. R. C. Murty, Mahesh Ranga, Muralidharan Kaliyaperumal   +7 more
wiley   +1 more source

A REVIEW ON QUALITY BY DESIGN APPROACHES TO ANALYTICAL METHOD DEVELOPMENT [PDF]

, 2019
Quality by Design (QbD) refers to a holistic approach towards the drug development. In pharmaceutical industries drug development is important and critical to achieve the best quality.
Rajendra Phadke1*, Dr. Amit Gosar2, Rupali Mali2, Deepesh Patil2
core   +1 more source

A-QbD-based green RP-HPLC method for estimation of rivaroxaban in pharmaceutical dosage forms

Discover Chemistry
This work reports the Analytical Quality by Design (AQbD) based green RP-HPLC method for Rivaroxaban, aimed at delivering a sustainable and robust analytical approach.
Yukta Vijay Kotecha, Dinesh Dattatray Rishipathak, Rakesh Uttamrao Shelke, Vijay Arjun Bagul, Anand Radheshyam Tiwari, Suryakant D. Bhosle   +5 more
doaj   +1 more source

ANALYTICAL QUALITY-BY-DESIGN (AQBD) APPROACH FOR THE DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OF LAMOTRIGINE IN BULK AND TABLET FORMULATION

Journal of Medical pharmaceutical and allied sciences, 2021
The current analytical exploration illustrated developing a reversed-phase high-performance liquid chromatography (RP-HPLC) technique and consequent substantiation for analyzing lamotrigine (LAM) active pharmaceutical ingredient (API) using a Quality-by-design (QbD) approach (Central Composite Design), in bulk product as well as in the tablet ...
openaire   +1 more source

A Systematic AQbD Approach for Optimization of the Most Influential Experimental Parameters on Analysis of Fish Spoilage-Related Volatile Amines [PDF]

, 2020
The volatile amines trimethylamine (TMA) and dimethylamine (DMA) could be used as important spoilage indices for seafood products, assisting in the determination of the rejection period.
Paulo Vaz-Pires, Freitas, Jorge, Silva, Pedro, José S. Câmara, Vaz-Pires, Paulo, Câmara, José S., Pedro Silva, Jorge Freitas   +7 more
core   +1 more source

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   +1 more source