Analytical Method Validation Report for Assay of Lapatinib by UPLC


Author(s): Sabyasachi Biswal*, Sumanta Mondal

A new, simple, rugged, rapid, robust and precise ultra-performance liquid chromatographic (UPLC) method for estimation of Lapatinib in a bulk and tablet dosage form has been developed and validated according to ICH Guidelines. Methods: The chromatographic separation was achieved using BHEL UPLC Column. The mobile phase used was a mixture of 0.1% OPA buffer 300 ml (30%) and 700ml Acetonitrile (70%) at isocratic mode and eluents were monitored at 309 nm using PDA detector. Results: By the method Lapatinib was eluted with retention time of 0.516 mins. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable and reproducible. Calibration curve plots were linear over the concentration ranges 10-50 μg/mL for Lapatinib. Limit of detection (LOD) were 0.06 μg/ml and limit of quantification (LOQ) were 0.18μg/mL for Lapatinib. Conclusion: The statistical analysis was proves the method is suitable for the estimation of Lapatinib as a bulk and tablet dosage form without any interference from the excipients