Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ALECTINIB IN BULK FORM AND PHARMACEUTICAL DOSAGE FORM

Devatha Suchitra Kumari*, Pasupuleti Sunitha, Vijaya Kuchana and G. Kalyani

ABSTRACT

A simple, precise, rapid and accurate reversed-phase high performance liquid chromatography (RP-HPLC) method for the estimation of Alectinib was developed and validated as per ICH Guidelines. Chromatography was carried out by isocratic technique on a Symmetry C18 ODS (4.6mm×250mm) 5µm particle size column with mobile phase mixture of Methanol: Phosphate Buffer (0.02M) (35:65%v/v) was used as a mobile phase and the pH was adjusted into 4.8 by using with ortho-phosphoric acid, at a flow rate of 1.0 ml/min. The signal was detected at 286 nm for Alectinib. The different analytical performance parameters such as linearity, precision, accuracy, and specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. The linearity of the calibration curves for each analyte in the desired concentration range is good (r2 >0.9). The recovery of the method was between 100.130% for Alectinib. Hence the proposed method is highly sensitive, precise and accurate and it successfully applied for the reliable quantification of bulk form and in the pharmaceutical dosage form of Alectinib.

Keywords: Alectinib, RP-HPLC, ICH Guidelines, Accuracy, Precision.