Development and Validation of a New RP-HPLC Method for the Estimation of Citalopram in Tablet Dosage Forms

Abstract

A novel, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of citalopram in tablet dosage forms. The method utilized an Agilent Eclipse XDB C18 column (150 x 4.6 mm, 5 µm) with a mobile phase consisting of acetate buffer (pH 4.5) and acetonitrile in a 65:35 v/v ratio, pumped at a flow rate of 1.0 mL/min. Detection was carried out at 240 nm, and the retention time for citalopram was found to be 3.727 minutes. The method demonstrated excellent linearity in the concentration range of 25, 150 µg/mL (r² = 0.999). Validation studies confirmed the method's precision, accuracy, specificity, and robustness, with recovery values ranging from 98.65% to 101.72%. The limits of detection (LOD) and quantification (LOQ) were determined to be 1.125 µg/mL and 3.375 µg/mL, respectively. The method was successfully applied to quantify citalopram in commercial tablet formulations, with results showing 100.1% recovery of the labeled claim. Forced degradation studies under acidic, basic, oxidative, thermal, photolytic, and neutral conditions revealed that the method could effectively separate citalopram from its degradation products, indicating its stability-indicating capability. The proposed method offers advantages over existing methods, including shorter analysis time (8 minutes), higher sensitivity, and a wider linearity range. It is concluded that this RP-HPLC method is suitable for routine quality control analysis of citalopram in pharmaceutical formulations.