1 University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Nagarjuna Nagar Guntur, Andhra Pradesh, India-522510
1,5 Department of Pharmaceutical Chemistry, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram Guntur, Andhra Pradesh, India-522019
2,6 Department of Pharmaceutical Chemistry, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh, India-522002
3,7 Department of Pharmaceutics, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram Guntur, Andhra Pradesh, India-522019
4 Department of Pharmacognosy, Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram Guntur, Andhra Pradesh, India-522019
* Corresponding Author: V Jhansi Rani. Email: jhansirani.vasa@gmail.com
Background:
Ritlecitinib is used for the treatment of severe alopecia areata. Ritlecitinib is a kinase inhibitor which inhibits Janus kinase 3 and tyrosine kinase. Thus, there is a greater interest in developing a unique and reliable UPLC approach for the determination of Ritlecitinib.
Objective:
To establish a novel quick and sensitive UPLC technique for the concurrent quantification of Ritlecitinib in rat plasma with Nilotinib as the internal standard.
Method:
Separation was carried on column Waters Symmetry C18 column, 150mm x 4.6mm, 3.5µm using an isocratic elution with a buffer containing 0.1% TFA was dissolved in 1 liter of HPLC grade water and adjust its pH-2.5 with Formic acid in the ratio of 60:40 ACN and Buffer as mobile phase with 0.2 mL/min flow rate at ambient temperature.
Results:
Analysis was carried out within 3 minutes over a good linear concentration range from 250ng/mL to 7500 ng/mL (r2 = 0.99994) for Ritlecitinib. The extraction recoveries and matrix effect of Ritlecitinib at different QC concentration levels, precision and recovery study results are within the acceptable limit. This procedure has been effectively implemented, examining Ritlecitinib and, along with its internal standard Nilotinib which were extracted from rat plasma utilizing liquid-liquid extraction.
Conclusion:
The medications demonstrated stability throughout the stability tests in accordance with USFDA criteria, as the validated technique effectively facilitated the pharmacokinetic investigations of the two drugs.
Keywords: UPLC, Ritlecitinib, Nilotinib, Bioanalytical Method, development, validation, Rat plasma.
How to cite this article: Jhansi Rani V, Govindarajan R, Udayavani S, Sultana SM, Vijetha P, Ravichandra S, Vidyadhara S. Bioanalytical Method Development and Validation of Ritlecitinib in Rat Plasma by UPLC and its Application to Pharmacokinetic Study. Int J Drug Deliv Technol. 2026;16(5): 199-209. DOI: 10.25258/ijddt.16.5.22
Source of support: Nil.
Conflict of interest: None