Volume : 11, Issue : 09, September – 2024
Title:
STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF IMATINIB MESYLATE BY RP-HPLC
Authors :
J.Jhansi, Dr. Varun, M.Kavya, B.Haritha, S.K. Godasu
Abstract :
A simple,fast and precise reverse phase high performance liquid chromatographic method (Rp-HPLC) good sensitivity was determined for the development and validation of Imatinib Mesylate. A Elico,corp.Japan UV-Visible spectrophotometer was used. The chromatographic separation was achieved on a waters C18 column,5um,150X4.6mm as stationary phase with mobile phase Methanol, Acetonitrile, Dichloromathane, Water, 0.1N NaOH, 0.1N HCl. An isocratic elution mode at 1.0mi/min flow rate and maintaining column temperature at ambient. The detection was monitored at 200-250nm for Imatinib Mesylate. The linearity was found to be in the range of 0-35ug/ml. The calibration factor is 0.9963. Imatinib Mesylate was subjected to p acidic, basic, oxidative, thermal and photolytic degradation. The drug was found to be stable in all the conditions. The developed method was simple, accurate, precise, specific, sensitive & reproducible. Stress testing should be given importance for quantification of degraded products of drugs helps us to maintain the quality, safety & efficacy of drugs in formulations.
Keywords: Imatinib mesylate, linearity, calibration factor, degradation.
Cite This Article:
Please cite this article in press J. Jhansi et al., Stability Indicating Method Development And Validation Of Imatinib Mesylate By RP-HPLC., Indo Am. J. P. Sci, 2024; 11 (09).
Number of Downloads : 10
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