Results 61 to 70 of about 279 (161)

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) based Analytical Method Development for Separation of Related Substances in Amodiaquine Hydrochloride along with its Degradation Products and Structural Elucidation by LC-Quadrupole-Time of Flight-Tandem Mass Spectrometry

Asian Journal of Chemistry, 2023
The current study aimed to develop a robust, regulatory-flexible, stability-indicating ultra high performance liquid chromatography (UHPLC) analytical procedure compatible with mass spectrometry for the determination of impurities in amodiaquine hydrochloride using analytical lifecycle management (ALM) and analytical quality by design (AQbD) principles.
Jaya Raju Cheerla, T. Bhaskara Rao, P. Sanath Kumar Goud   +2 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

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

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

Development of a robust and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method using analytical quality by design principles for the accurate determination of esculin in its bulk form

Future Journal of Pharmaceutical Sciences, 2023
Background Analytical quality by design is a proactive, holistic, and data-driven approach to quality that emphasizes risk assessment and management. This can lead to more robust and reliable methods than traditional approaches.
Sarvesh Patil, Anjana Adhyapak, Priya Shetti, Rohan Gurao   +3 more
doaj   +1 more source

Implementation of Analytical Quality by Design (AQbD) approach to RP-HPLC method for dissolution testing

, 2015
Quality by Design (QbD) principles were implemented in RP-HPLC method development for the analysis of dissolution samples of immediate release film-coated tablets. Critical method variables and critical method attributes were identified. After the initial risk assessment, a DoE (design of experiments) study was performed to investigate the impact of ...
Pranjić, Josip, Radošević, Senka, Lusina Kregar, Maja   +2 more
openaire   +2 more sources

The use of QbD for the development and validation of a stability-indicating RP-HPLC method for the quantitation of nevirapine in bulk, tablet and niosome formulations

Frontiers in Analytical Science
IntroductionA reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitation of nevirapine (NVP) in bulk drug, commercial tablets, and niosome formulations using an Analytical Quality by Design ...
Bwalya A. Witika, Roderick B. Walker
doaj   +1 more source

Central composite design (CCD) approach to develop HPLC method for caffeine: Application to coffee samples analysis of Jazan region, Saudi Arabia

Journal of Saudi Chemical Society
The goal of this study was to use High performance liquid chromatography (HPLC) with an Analytical Quality by Design (AQbD) approach to measure the amount of caffeine in selected coffee samples available in the local Jazan market in Saudi Arabia.
Asim Najmi, Zia ur Rehman, Khalid Zoghebi, Hassan Ahmed Alhazmi, Mohammed Mofarreh Albratty, Qasem Yahya Hassan Haroobi, Ismail Mohammed Ali Sayram, Mohammed Ahmed Saleh, Waleed Mohammed Ahmed Qaser, Abdulaziz Ali Houssein Qaysi   +9 more
doaj   +1 more source

Application of the concept of design space in method development for the determination of contaminants in soil [PDF]

Proceedings of the Estonian Academy of Sciences
The analysis of polycyclic aromatic hydrocarbons and polychlorinated biphenyls is an important topic in environmental analysis, and several analysis procedures have already been proposed.
Jelena Jurjeva, Mihkel Koel
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