Method development and validation of RP-HPLC method for estimation of imatinib mesylate in pure and pharmaceutical dosage form

[摘要] An accurate, precise, simple and economical RP- HPLC method has been developed for the rapid estimation of Imatinib Mesylate in pure and pharmaceutical formulation. The separation was achieved on C18 G column ( 250 x 4.6 mm i.d, 5 μm), using o-Phosphoric acid (0.1% v/v): Acetonitrile 70:30 (v/v) as mobile phase, at a flow rate of 1.0 ml/min. Detection was carried out at 266 nm and drug eluted with a retention time of 3.25 min. Beer’s law was obeyed in the concentration range of 5-30 μg/ml with correlation coefficient 0.999. The method had been validated according to ICH guide lines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The proposed method was convenient for quantitative routine analysis and quality control of Imatinib Mesylate in bulk and pharmaceutical dosage form.

[学科分类] 药理学