000			01998nam a2200157 4500
008			250220b |||||||| |||| 00| 0 eng d
082			_bP.46-56
100			_aSwetha Sri Remidicherla
245			_aMETHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF IMATINIB MESYLATE SPIKED IN VITRO SALIVA BY LC-MS/MS
300			_aP.46-56
520			_aA 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.
654			_aImatinib mesylate _aLOD _aLOQ _aICH Q2 (R1) _aLC-MS/MS
700			_aGuntupalli Chakravarthi
773	0		_0125265 _9109669 _dMumbai Indian Drugs Manufacturer's Association _tIndian Drugs _x0019-462X
942			_cJA
999			_c131175 _d131175