An overview of experimental designs in HPLC method development and validation

PK Sahu, NR Ramisetti, T Cecchi, S Swain… - … of pharmaceutical and …, 2018 - Elsevier
Chemometric approaches have been increasingly viewed as precious complements to high
performance liquid chromatographic practices, since a large number of variables can be …

Drilling into “Quality by Design” approach for analytical methods

L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

Critical review of reports on impurity and degradation product profiling in the last decade

S Görög - TrAC Trends in Analytical Chemistry, 2018 - Elsevier
Drug impurity and degradation profiling mean the detection, structure elucidation and
quantitative determination of impurities and degradation products in bulk drug materials and …

Green analytical chemistry and experimental design: a combined approach for the analysis of zonisamide

SG Elsheikh, AME Hassan, YM Fayez… - BMC chemistry, 2023 - Springer
Green analytical chemistry principles, as well as experimental design, are a combined
approach adopted to develop sensitive reproducible stability indicating HPLC method for …

Development and validation of a stability-indicating liquid chromatographic method for estimating olmesartan medoxomil using quality by design

S Beg, G Sharma, OP Katare, S Lohan… - Journal of …, 2015 - academic.oup.com
The current studies entail systematic quality by design (QbD)-based development of a
simple, rapid, sensitive and cost-effective stability-indicating method for the estimation of …

Development of an innovative quality by design (QbD) based stability-indicating HPLC method and its validation for clofazimine from its bulk and pharmaceutical …

TS Patil, AS Deshpande - Chromatographia, 2019 - Springer
The present research work discusses the systematic Quality by Design (QbD) enabled
development of a simple, rapid, economical, and stability-indicating high-performance liquid …

Analytical quality by design approach in RP-HPLC method development for the assay of etofenamate in dosage forms

R Peraman, K Bhadraya, YP Reddy… - Indian journal of …, 2015 - pmc.ncbi.nlm.nih.gov
By considering the current regulatory requirement for an analytical method development, a
reversed phase high performance liquid chromatographic method for routine analysis of …

Optimization and validation in liquid chromatography using design of experiments

L Latrous - Chemistry Africa, 2022 - Springer
Faced to the large number of potential factors in liquid chromatography, the analyst is often
led to determine through his experience the parameters to be studied. Experimental designs …

QbD-based development and validation of a stability-indicating HPLC method for estimating ketoprofen in bulk drug and proniosomal vesicular system

NK Yadav, A Raghuvanshi, G Sharma… - Journal of …, 2016 - academic.oup.com
The current studies entail systematic quality by design (QbD)-based development of simple,
precise, cost-effective and stability-indicating high-performance liquid chromatography …

An application of quality by design and analytical greenness assessment approach for the development of erlotinib stability indicating method

S Gundecha, M Patel, YC Mayur - Chromatographia, 2022 - Springer
Pharmaceutical regulators are worried about medication quality and stability since drug
degradation may result in harmful chemicals. Erlotinib (ERL) is a tyrosine kinase inhibitor …