Results 61 to 70 of about 299 (155)

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
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Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

Pharmaceutics, 2020
A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein   +5 more
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
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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

A COMPREHENSIVE REVIEW ON ADVANCING PHARMACEUTICAL ANALYSIS THROUGH ANALYTICAL QUALITY BY DESIGN (AQBD)

Background: Pharmaceutical analytical methods are very important for ensuring drug quality. However traditional methods often rely on trial and error. This can lead to methods that're not very robust or flexible. Analytical Quality by Design (AQbD) is an approach. It uses science-based principles for analytical methods.
Manish Kumar Barala, Dr. Mukesh Bansal, Dr. Dilip Agrawal   +2 more
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Integration of analytical quality by design green and white analytical chemistry in RP-HPLC method development

Discover Chemistry
Reverse-phase high-performance liquid chromatography (RP-HPLC) has continued to remain one of the most extensively employed analytical techniques in pharmaceutical analysis, with its high robustness, accuracy, and applicability.
Sushma Madhavaram, Judy Jays
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 ...
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A Mini Overview of Analytical Quality by Design (AQbD)

A methodical, science- and risk-based approach to pharmaceutical development, Quality by  Design (QbD) emphasizes incorporating quality into goods rather than depending just on end product testing. Through standards like ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk  Management), and Q10 (Pharmaceutical Quality System), regulatory bodies ...
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Analytical method development, validation for the estimation of brivaracetam in bulk drug substance by RP-HPLC and identification of its major degradation product: a quality by design approach

Future Journal of Pharmaceutical Sciences
Background The research involved a systematic and proactive approach, integrating quality considerations throughout the product lifecycle, from initial conception to final production.
Sandip Kumar Dey, Koustav Dutta, Sumanta Mondal, Sagar Suman Panda, Prasenjit Mondal   +4 more
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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