Abstract

METHOD DEVELOPMENT AND VALIDATION OF ALECTINIB DRUG BY RP HPLC BULK AND PHARMACEUTICAL DOSAGE FROM

Sathish Kumar, Suresh Kannan*, Kalaiselvi, Senthilkumar Natesan

ABSTRACT

A novel, simple, precise, and accurate Reverse-Phase High-Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the estimation of Alectinib in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on a Zorbax Eclipse XDB-C18 column (150 × 4.6 mm, 5 µm) using an isocratic mobile phase consisting of Acetonitrile and Water (50:50 v/v), adjusted to pH 3.0 with orthophosphoric acid. The flow rate was 0.8 mL/min, and detection was carried out using a PDA detector at 265 nm. The retention time for Alectinib was found to be 3.3 minutes. The method was validated as per ICH Q2(R1) guidelines. The calibration curve was linear over the concentration range of 10-50 µg/mL (r² = 0.9989). The method demonstrated excellent precision (%RSD < 1) and accuracy (recovery between 98.5% and 100.6%).The limits of detection (LOD) and quantitation (LOQ) were 0.18 µg/mL and 0.57 µg/mL, respectively. The proposed method was successfully applied for the assay of a marketed tablet formulation (Alecensa®), yielding a result of 99.2% of the label claim. This method is rapid, reliable, and suitable for routine quality control analysis of Alectinib.

Keywords: Alectinib, RP-HPLC, Method Development, Validation, ICH Guidelines, Pharmaceutical Analysis, Alecensa.