Development and Validation of A Stability-Indicating RP-HPLC Method for Citalopram

Abstract

A reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of citalopram in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved on an Agilent Eclipse XDB C18 column (150 × 4.6 mm, 5 µm) using acetate buffer (pH 4.5) and acetonitrile in a 65:35 (v/v) ratio as the mobile phase. The flow rate was 1.0 mL/min, column temperature was maintained at 30°C, injection volume was 10 µL and detection was performed at 240 nm. The retention time of citalopram was approximately 3.727 min and the total run time was 8 min. The method was evaluated for linearity, precision, accuracy, limit of detection, limit of quantitation, robustness, system suitability and applicability to tablet dosage forms. Linearity was demonstrated over 25–150 µg/mL with a reported regression equation of y = 15390x + 48483 and R² = 0.9991. Repeatability and intermediate precision produced %RSD values of 0.47% and 0.32%, respectively. Mean recoveries at 50, 100 and 150 µg/mL were approximately 99.60%, 101.40% and 99.57%, respectively. The reported LOD and LOQ were 1.125 and 3.375 µg/mL. Analysis of Celepra tablets gave 100.1% recovery of the labelled citalopram content. The method was also applied to stress-treated samples under acidic, alkaline, thermal, oxidative, photolytic and neutral conditions. The study data support the suitability of the proposed RP-HPLC procedure for quantitative analysis of citalopram in the studied pharmaceutical formulation.