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 and its related substances. The analyzed active pharmaceutical ingredient and its impurities were separated by Atlantis T3 (150 mmx4.6 mm), 3 mu m column with ultraviolet detection at 230 nm. The mobile phase has been used in specific composition (50:50, v/v, organic and inorganic) that was prepared using methanol and buffer (0.01 M of 1-Octane sulphonic acid with 0.2 % trifluoroacetic acid). The results of proposed method were analyzed and validated as per International council on harmonisation guidelines. The percentage relative standard deviation was observed as 1.15 % for system precision that was found within the limit. The method was found to be specific as there was no interference between blank, imatinib mesylate and impurities. The limit of detection and quantitation was found 0.383 and 1.15 ppm respectively. The regression coefficient (r2) of imatinib mesylate and its impurities was found to be 0.999. Recovery results of impurities imatinib-piperazine-n-oxide and n-desmethyl-imatinib were found 107.70 % and 99.30 % against standard which was within 80 %-120 % acceptance criteria. The molecule was stable in all the stress conditions such as acid, base, oxidation, thermal and also in analytical solution. Thus, proposed method was found to be sensitive, accurate, precise, reproducible and offered good column life and also beneficial for study of impurities.