Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Related Substances of Imatinib Mesylate

In the present work high performance liquid chromatography method was developed and validated for imatinib mesylate its related substances. The analyzed active pharmaceutical ingredient impurities were separated by Atlantis T3 (150 mm×4.6 mm), 3 μm column with ultraviolet detection at 230 nm. mobile phase has been used in specific composition (50:50, v/v, organic inorganic) that prepared using methanol buffer (0.01 M of 1-Octane sulphonic acid 0.2 % trifluoroacetic acid). results proposed as per International council on harmonisation guidelines. percentage relative standard deviation observed 1.15 system precision found within limit. to be there no interference between blank, impurities. limit quantitation 0.383 ppm respectively. regression coefficient (r2) 0.999. Recovery imatinib-piperazine-n-oxide n-desmethyl-imatinib 107.70 99.30 against which 80 %-120 acceptance criteria. molecule stable all stress conditions such acid, base, oxidation, thermal also analytical solution. Thus, sensitive, accurate, precise, reproducible offered good life beneficial study