Results 91 to 100 of about 1,038 (200)

Potency Assay Variability Estimation in Practice

Pharmaceutical Statistics, Volume 24, Issue 1, January/February 2025.
Abstract During the drug development process, testing potency plays an important role in the quality assessment required for the manufacturing and marketing of biologics. Due to multiple operational and biological factors, higher variability is usually observed in bioassays compared with physicochemical methods.
Hang Li, Tomasz M. Witkos, Scott Umlauf, Christopher Thompson   +3 more
wiley   +1 more source

Development and Validation of a Stability Indicating Analytical Method for the Estimation of Gliclazide and Sitagliptin in Bulk Drugs and Tablet Dosage Forms by RP-UPLC: An Application of the Quality-by-Design Approach [PDF]

Sitagliptin and gliclazide are the active ingredients in OpdualagTM. A highly selective DPP-4 inhibitor, sitagliptin is thought to work in type 2 diabetics by delaying the inactivation of incretin hormones, which increases their concentration and ...
Nunsavathu, Sambasiva Naik, Rajaganapathy, Dr. K.   +1 more
core   +2 more sources

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

Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

International Journal of Analytical Chemistry, 2021
The use of analytical quality by design (AQbD) approach in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool.
Nabil K. Alruwaili
doaj   +1 more source

Implementation of at-line capillary zone electrophoresis for fast and reliable determination of adenovirus concentrations in vaccine manufacturing [PDF]

, 2019
A CZE method was validated and implemented for fast and accurate in-process determination of adenovirus concentrations of downstream process samples obtained during manufacturing of adenovirus vector-based vaccines.
Backus, Harold, Galindo Garre, Francisca, Germano, Marta, Geurink, Lars, Schenning, Martijn, Somsen, Govert W., Sänger – van de Griend, Cari E., van Tricht, Ewoud   +7 more
core   +3 more sources

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

An analytical quality by design approach towards a simple and novel HPLC-UV method for quantification of the antifibrotic peptide N-acetyl-seryl-aspartyl-lysyl-proline [PDF]

, 2022
N-acetyl-seryl-aspartyl-lysyl proline (Ac-SDKP) is a tetrapeptide possessing anti-fibrotic, angiogenic, anti-inflammatory, anti-apoptotic, and immunomodulatory properties. Currently, the main method to quantify the peptide is liquid chromatography-tandem
Abukhamees, Shorooq, Craig, Duncan QM, Day, Richard M, Kenneth Ho, Hei Ming, Sembi, Satinder   +4 more
core  

OPTIMIZING RP-HPLC TECHNIQUES FOR RELIABLE ANALYSIS OF DIABETES MEDICATIONS [PDF]

Introduction: A robust and precise RP-HPLC method was developed for the simultaneous quantification of Metformin, Vildagliptin, and Remogliflozin in pharmaceutical formulations, essential for managing Type 2 Diabetes Mellitus (T2DM).
Venkata sai suresh kumar sista* , Anjali jha, V LNSH Hari Haran. A, R S K Sharma , Anindita Chatterjee, G V Siva Prasad, K. Satyam Naidu, R. Sarada
core   +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