A Novel Ultra Performance Liquid Chromatography-PDA Method Development and Validation for Alectinib in Bulk and its Application to Tablet Dosage Form

Abstract

Objectives: To develop a novel ultra-performance liquid chromatographic technique for the estimation of alectinib in a API and tablet. Methods: The chromatographic separation was achieved using DIKMA Endoversil (2.1 x 50mm, 1.7μm) column, mobile phase was phosphate buffer, pH 4.6 and methanol as a mobile phase (45:55) with a flow rate of 0.4 mL/min and eluent was monitored at 265 nm. The method was continued and validated in accordance with International conference on harmonization guidelines. Validation study revealed the specificity and reliability of the method. Results: In this method alectinib was eluted with retention time of 0.418 min. Calibration curve plots were found linear over the concentration ranges 1-100 μg/mL for alectinib. Limit of detection was 0.015μg/ml and limit of quantification was found 0.07μg/mL. The % assay of the marketed dosage form was found 97.80 %, even the present approach was found to be effective in the analysis of alectinib in force degradation condition. Conclusion: The experiential evidences of all the study results revealed the suitability of the estimation of alectinib in API and tablet formulation.