Method Development and Validation for Assay and Related Substance of Imatinib Mesilate in Bulk and Tablet Dosage form using RP-HPLC

A new method was developed and validated to assay imatinib mesilate and its impurities in drug substance and dosage forms. The developed method can be utilized to determine drug content and its related substances. The method validation study proves that the method is accurate, precise, specific and robust. The imatinib mesilate has five specified impurities and can be easily determined using this methodology. All impurities and imatinib peak are resolved using XB ridge C18, 250 mm x 4.6 mm, 5 μm column. A mixture of acetate buffer pH 9.5 and a mixture of methanol and acetonitrile in gradient mode are separated. The wavelength is selected at 264 nm with a column temperature of 30°C and a run time of 45 minutes. Linearity covered from 0.3 to 1985 μg/mL. The method has been validated as per ICH Q2 (R1) guidelines. Forced degradation study is performed using this method and proved that the method is stability-indicating and suitable for use.