Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study

Sathish Sabbani; Chakravarthi Guntupalli; Narender Malothu

doi:10.12991/jrespharm.1944972

Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study

Abstract

liIn this work, the amount of Ritlecitinib in rat plasma was determined using a liquid chromatography- tandem mass spectrometry approach. Crizotinib is an internal standard(IS). With a 3.5µm particle size and dimensions of 150 x 4.6 mm, the Waters X-Terra RP-18 column was used for the chromatographic separation. Acetonitrile: TEA pH- 2.5/Formic acid in a 60:40% v/v ratio was used as the mobile phase at a flow rate of 1.0 mL/min. The drug and IS were extracted using the liquid-liquid extraction technique. Proton adducts of Ritlecitinib and Crizotinib were detected at m/z 286.159-105.7458 and 451.3378-282.4251, respectively, in the positive mode of multiple reaction monitoring (MRM). The validation was carried out within the linear concentration range of 12.50–100.0 ng/mL. The coefficient of variation (%CV) for Ritlecitinib was determined to be 2.80% and 96.47%. Further, the precision and accuracy results for HQC, MQC, LQC, and LLQC were determined to be 98.02%, 98.42%, 98.62%, and 96.13%. With this method the average recovery rate was found to be 98.78%.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmacology and Pharmaceutical Sciences (Other)

Journal Section

Research Article

Authors

Sathish Sabbani This is me
India

Chakravarthi Guntupalli ^* This is me
0000-0003-3777-3157
India

Narender Malothu
0000-0002-3069-5742
India

Publication Date

May 11, 2026

Submission Date

August 18, 2024

Acceptance Date

January 11, 2025

Published in Issue

Year 2026 Volume: 30 Number: 3

DOI

https://doi.org/10.12991/jrespharm.1944972

IZ

https://izlik.org/JA94JB64ZU

Cite

RIS / Bibtex

APA

Sabbani, S., Guntupalli, C., & Malothu, N. (2026). Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study. Journal of Research in Pharmacy, 30(3), 868-881. https://doi.org/10.12991/jrespharm.1944972

AMA

1.Sabbani S, Guntupalli C, Malothu N. Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study. J. Res. Pharm. 2026;30(3):868-881. doi:10.12991/jrespharm.1944972

Chicago

Sabbani, Sathish, Chakravarthi Guntupalli, and Narender Malothu. 2026. “Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib As an Internal Standard in Rat Plasma and Its Application to Pharmacokinetics Study”. Journal of Research in Pharmacy 30 (3): 868-81. https://doi.org/10.12991/jrespharm.1944972.

EndNote

Sabbani S, Guntupalli C, Malothu N (May 1, 2026) Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study. Journal of Research in Pharmacy 30 3 868–881.

IEEE

[1]S. Sabbani, C. Guntupalli, and N. Malothu, “Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study”, J. Res. Pharm., vol. 30, no. 3, pp. 868–881, May 2026, doi: 10.12991/jrespharm.1944972.

ISNAD

Sabbani, Sathish - Guntupalli, Chakravarthi - Malothu, Narender. “Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib As an Internal Standard in Rat Plasma and Its Application to Pharmacokinetics Study”. Journal of Research in Pharmacy 30/3 (May 1, 2026): 868-881. https://doi.org/10.12991/jrespharm.1944972.

JAMA

1.Sabbani S, Guntupalli C, Malothu N. Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study. J. Res. Pharm. 2026;30:868–881.

MLA

Sabbani, Sathish, et al. “Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib As an Internal Standard in Rat Plasma and Its Application to Pharmacokinetics Study”. Journal of Research in Pharmacy, vol. 30, no. 3, May 2026, pp. 868-81, doi:10.12991/jrespharm.1944972.

Vancouver

1.Sathish Sabbani, Chakravarthi Guntupalli, Narender Malothu. Bioanalytical Method Development and Validation of Ritlecitinib Using Crizotinib as an Internal Standard in Rat Plasma and its Application to Pharmacokinetics Study. J. Res. Pharm. 2026 May 1;30(3):868-81. doi:10.12991/jrespharm.1944972