Analytical Method Development and Validation for Estimation of Lapatinib in Formulation by RP-HPLC with Stability Indicating

Abstract

Reverse-phase high-performance liquid chromatography (RP-HPLC) approach for Lapatinib in pharmaceutical dosage form development and validation. Reverse phase chromatography is easy, practical, and superior in terms of effectiveness, stability, and repeatability. Lapatinib was chosen to be separated using the C18 column, a 250 x 4.6 mm column with 5.0µm particle packing. As lapatinib was exhibiting good peak morphologies and a large amount of resolution, it was created with a mobile phase of water, methanol, and trifluroacetic acid (30:70:0.1) v/v. The analytes were detected at 262nm using a UV detector while the mobile phase was flowing at 1.1 ml/min. Specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation were used to develop the method and validate it.The method demonstrated a dynamic linear response at 25-75 µg/ml and was shown to be linear with a correlation coefficient (r2) of above 0.999 and limits of detection and quantitation (LOD and LOQ) of 0.45 and 1.35µg, respectively. Degradation of the sample was used to establish the stability indicating RP-HPLC procedures, which were then compared to standards. The relative standard deviation as a percentage was also less than 2%, demonstrating the suggested method's high level of precision.