Ultrafast monolithic HPLC method for simultaneous quantification of the anticancer agents, imatinib and sorafenib: Application to tablet dosage forms
Purpose: To develop and validate a simple ultrafast monolithic high performance liquid chromatography (HPLC) method for the simultaneous quantification of two anti-cancer agents, imatinib and sorafenib, in pure form and tablet preparations.
Method: Chromatographic separation was accomplished using Chromolith flash RP-18 HPLC-column (25 - 4.6 mm; macropores, 2 μm; mesopores, 13 – 15 nm). The optimum mobile phase composition of ammonium acetate buffer (10 mM, pH 8.5) and methanol at ratio of 35:65 v/v was used. Effluent flow rate was adjusted to 1.0 mL/min and the analysis was performed at 250 nm wavelength. The developed method was evaluated for specificity, linearity, precision and accuracy.
Results: The method offered a linear relationship over the concentration range of 1 - 16 μg/ml (correction coefficient, R2 = 0.9999) for both analytes. Limit of detection (LOD) was 0.1891 and 0.1888 μg/ml while limit of quantification (LOQ) was 0.6303 and 0.6294 μg/ml for imatinib and sorafenib, respectively. Mean recovery was within 100 ± 2 %. The utility of the new method was demonstrated by its successful use for the analysis of commercially available tablet formulations of both drugs.
Conclusion: The developed method is fast and economical, and is being recommended for routine analysis of imatinib and sorafenib in bulk drug and tablet dosage forms in quality control laboratories.
Keywords: RP-HPLC, Chromolith, Imatinib, Sorafenib, Validation, Quality control