International Journal of Drug Delivery Technology
Volume 14, Issue 2

Development of a Bioanalytical Assay for the Selective RET Inhibitor Pralsetinib in Plasma Samples Utilizing Liquid Chromatography-Tandem Mass Spectrometry

Vijetha Pendyala1*, Susmitha Priyadarsini Addanki2, Vidyadhara Suryadevara1

1Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram Guntur, Andhra Pradesh, India

2College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India. 

Received: 07th January, 2024; Revised: 21st March, 2024; Accepted: 16th May, 2024; Available Online: 25th June, 2024 

ABSTRACT

Pralsetinib is a potent and specific tyrosine kinase inhibitor targeting the RET receptor, used in treating various cancers. This study developed and validated a bioanalytical assay for pralsetinib in plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The internal standard was erlotinib, and protein precipitation with acetonitrile was used for sample preparation. The analytes were separated on an Ultimate® XB-C18 column using gradient elution with ammonium acetate in water and methanol. Both are acidified with 0.1% formic acid. Detection was performed using positive electrospray ionization in the chosen reaction monitoring mode. The assay was validated over a linear range of 2 to 2000 ng/mL, achieving accuracies greater than 90% and precision values below 2%. The method was stable under all tested conditions without significant matrix effects or extraction losses.

Keywords: LC-MS/MS, Validation, Bio-analysis, Pralsetinib, Erlotinib, Internal standard.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.36

How to cite this article: Pendyala V, Addanki SP, Suryadevara V. Development of a Bioanalytical Assay for the Selective RET Inhibitor Pralsetinib in Plasma Samples Utilizing Liquid Chromatography-Tandem Mass Spectrometry. International Journal of Drug Delivery Technology. 2024;14(2):847-852.

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