A Novel RP-HPLC Method For Imatinib Mesylate Impurity Profiling

Abstract

Imatinib mesylate is a mesylate salt, specifically the monomesylate salt of imatinib. Employed in the management of chronic myelogenous leukaemia, various malignancies, haematological disorders, and gastrointestinal stromal tumours. It functions as an antineoplastic agent, an inducer of apoptosis, a tyrosine kinase inhibitor, and an agent against coronaviruses. The primary aim of the research was to elucidate the process of impurity separation, accomplished through the development and validation of an analytical method for quantifying the impurities present in imatinib mesylate. This method presents a distinct advantage, as there are only a limited number of analytical techniques documented for the quantification of imatinib and its related substances in both bulk and pharmaceutical formulations. Five impurities were successfully isolated, and a method was developed and validated utilising HPLC on a Zodiac C18 (150 mm × 4.6 mm, 5 μm) column within a gradient elution scheme. The wavelength for detection was established at 240 nm. The retention time for the drug was recorded at 27.2 minutes, with the analysis concluding within a span of 45 minutes. The samples are subjected to the forced degradation conditions—hydrolysis, oxidation, acidic, basic, and dry heat—specified by the International Conference on Harmonisation. The technique distinguished between unknown substances and five known impurities. Related Compound 1, Related Compound 2, Related Compound 3, Impurity 3, and Impurity B. According to the International Conference on Harmonization's guidelines, the method was validated in terms of specificity, linearity, precision, accuracy, and limits of detection and quantification