ELECTROPHORESIS, Volume 42, Issue 1-2, Page 10-18, January 2021., 2021 Abstract Vaccines against infectious diseases are urgently needed. Therefore, modern analytical method development should be as efficient as possible to speed up vaccine development. The objectives of the study were to identify critical method parameters (CMPs) and to establish a set of steps to efficiently develop and validate a CE‐SDS method for ...
Lars Geurink +4 more
wiley +1 more source
Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
International Journal of Analytical Chemistry, 2015 Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach.
Ramalingam Peraman +2 more
doaj +1 more source
Experimental design in HPLC separation of pharmaceuticals [PDF]
Arhiv za farmaciju, 2021 Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number of chromatographic parameters to ensure optimal separation in High Pressure Liquid Chromatography (HPLC).
Stojanović Jevrem +5 more
doaj +1 more source
Molecules, 2021 A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form.
Jesús Alberto Afonso Urich +5 more
doaj +1 more source
Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach [PDF]
, 2020 A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing.
CHANDAN RAVANDUR SHIVANNA +2 more
core +2 more sources
Journal of Chemistry, 2015 Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman +2 more
doaj +1 more source
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 BiltenIn 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 +5 more
doaj +1 more source
Robust optimization of gradient RP HPLC method for simultaneous determination of ivabradine and its eleven related substances by AQbD approach [PDF]
, 2021 This paper is aimed at developing a gradient elution reversed-phase high-performance liquid chromatography (RP-HPLC) method for the separation of a complex mixture composed of ivabradine and its eleven impurities, in a reasonable timeframe.
Agbaba, Danica +5 more
core +1 more source
Analytical Method Validation: A Comprehensive Review of Current Practices [PDF]
Analytical method validation is a critical process in industries such as pharmaceuticals, food safety, biotechnology, and environmental monitoring. It guarantees reliability, reproducibility, and compliance with regulatory obligations. This review covers
Sachin S. Shinde, Dr. Preeti Khulbe
core +5 more sources
A new approach based on inversion of a partial least squares model searching for a preset analytical target profile. Application to the determination of five bisphenols by liquid chromatography with diode array detector [PDF]
, 2021 The paper shows a procedure for selecting the control method parameters (factors) to obtain a preset ‘analytical target profile’ when a liquid chromatographic technique is going to be carried out for the simultaneous determination of five bisphenols ...
Arce Antón, Mar +5 more
core +1 more source