Statistical optimization and validation of a novel ultra-performance liquid chromatography method for estimation of nintedanib in rat and human plasma

A high throughput ultra-performance liquid chromatography (UPLC)-ultraviolet method for quantification of nintedanib in rat and human plasma was developed and optimized using chemometrical approach. Design of experiment and multivariate statistical approach was used for definition of optimized metho...

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Bibliographic Details
Published inBioanalysis Vol. 12; no. 3; pp. 159 - 174
Main Authors Shukla, Snehal K, Kadry, Hossam, Bhatt, Jayshil A, Elbatanony, Rasha, Ahsan, Fakhrul, Gupta, Vivek
Format Journal Article
LanguageEnglish
Published England Newlands Press Ltd 01.02.2020
Newlands Press
Subjects
Acetonitrile
Animals
Antineoplastic Agents - blood
Antineoplastic Agents - pharmacology
Bioavailability
Chromatography
Chromatography, Liquid - methods
Design of experiments
design of experiments (DOE)
Humans
Indoles - blood
Indoles - pharmacology
Ions
Liquid chromatography
Methods
nintedanib
Optimization
Pharmacokinetics
Plasma
Potassium
Potassium phosphate
preclinical
principal component analysis (PCA)
Principal components analysis
Quality control
Rats
statistical analysis
Statistics
UPLC-UV
United States > US
preclinical
principal component analysis (PCA)
design of experiments (DOE)
pharmacokinetics
nintedanib
statistical analysis
UPLC-UV
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Summary:A high throughput ultra-performance liquid chromatography (UPLC)-ultraviolet method for quantification of nintedanib in rat and human plasma was developed and optimized using chemometrical approach. Design of experiment and multivariate statistical approach was used for definition of optimized method. Final separation was performed using protein precipitation method on ACQUITY HSS T3 C18 column in isocratic mode using potassium phosphate buffer (pH 7.5): acetonitrile. Method was validated as per US-FDA guidelines linearly from 15–750 ng/ml. All quality control samples showed <15% relative standard deviation for precision and 85–115% accuracy along with >98% extraction recovery. The developed method is easily applicable in determining pharmacokinetic parameters in preclinical subjects along with successful implementation for quantification in human plasma samples.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2019-0284