Chloroquine Phosphate HPLC Assay and Impurity Profiling Methods Following the USP Monograph

Introduction

A rapid, accurate, and simple method was implemented for the total chromatographic purity analysis of Chloroquine Phosphate by High Performance Liquid Chromatography with a Diode Array Detector. The experimental conditions follow guidelines, with minor modifications, from the USP43-NF38 monograph methods for Chloroquine Phosphate Assay and Impurity Profiling. Chloroquine Phosphate, Chloroquine Related Compound A, Chloroquine Related Compound D, Chloroquine Related Compound E, Chloroquine Related Compound G, Hydroxychloroquine, and Phenol can be resolved with baseline separation within 16 minutes using an Ascentis Express C18 column (250 x 4.6 mm, 5 µM). A 1.4 g/L Dibasic sodium phosphate solution (pH 3.0) in water: 0.4% triethylamine in methanol (30:70 v/v) were employed as the mobile phase for the isocratic elution. Under applied conditions, system suitability criteria are met, and the method demonstrates good resolution/selectivity, reproducibility, and sensitivity.