Shukla-Nintedanib UPLC-Bioanalysis-2020.pdf

Aim: 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. Method: 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. Results: 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.

Conclusion: The developed method is easily applicable in determining pharmacokinetic parameters

in preclinical subjects along with successful implementation for quantification in human plasma samples.