Article Details

METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF IMATINIB MESYLATE SPIKED IN VITRO SALIVA BY LC-MS/MS

Swetha Sri Remidicherlaa,b, Guntupalli Chakravarthib*, Pravallika S.b, Alavala Rajasekhar Reddyb and GSN Koteswara Raob

a Department of Pharmaceutical Analysis, Sarojini Naidu Vanita Pharmacy Maha Vidyalaya, Vijayapuri Colony, Tarnaka – 500 017, Secunderabad, Telangana, India

b K L College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram – 522 502, Guntur, Andhra Pradesh, India

For Correspondence: E-mail: chakra_varthi123@kluniversity.in

 

https://doi.org/10.53879/id.61.04.13917


ABSTRACT

A novel, sensible, rapid, reliable and economical analytical hyphenated LC-MS/MS method has been developed as a key for the safety surveillance in chronic leukemia patients, and as a part of therapeutic drug monitoring of imatinib mesylate in human saliva. Imatinib mesylate or imatinib methane sulfonate is a tyrosine kinase inhibitor, apoptosis inducer and also known to be an anticoronaviral agent. Imatinib mesylate is a monomesylate salt of imatinib used for the treatment of gastrointestinal tumors and chronic myelogenous leukemia, and also in other complex malignancies. The lmax of imatinib mesylate was observed at 258 nm by UV spectrometry, establishing a very good linearity along with sensitivity. The detection limit (LOD) =0.2925 µg mL-1 and quantitation limit (LOQ)= 0.8977 µg mL- ¹ were obtained from the linear concentrations taken in the range of 2-12 µg mL-1. The correlation coefficient (r2 ) found was 0.999. The method validation parameters according to ICH Q2 (R1) were performed. The developed method described here, UPLC-MS/MS, was found to be novel, sensitive and rapid with improved results when successfully tested for human saliva samples without significant differences in the steady state imatinib mesylate concentrations. Current method could overcome the safety issues during therapeutic drug monitoring and pharmacokinetic behavior of the drug when tested clinically.

Year 2024 | Volume No. 61 | Issue No.4 | Page No. 46-56
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