Development and Validation of Stability Indicating Assay Methods (SIAMs)for Citalopram HBr by Using UV-Visible Spectrophotometer and RP-HPLC

摘要

A simple, fast, accurate and precise method has been developed UV-Vis spectrophotometric method for the estimation of citalopram HBr in bulk and pharmaceutical dosage form. The solvent used was distilled water and the absorption maxima. (λ max) of drug was found 239 nm. A linear response was observed in the range of 4-20 μg/ml with a regression coefficient of 0.999. Citalopram HBr was subjected to acid hydrolysis, alkali hydrolysis, oxidation, photo and thermal degradation. The citalopram shows relative high thermal and photo stability. i.e.(0.15% at 48 hours and 0.21% at 72 hours) as compared to other stability conditions. The reversed-phase high performance liquid chromatography method has been developed for citalopram HBr. The separation and degradation product was carried out on C18 column Phenomenex-250×4.6mm×5μm using mobile phase consisting of acetonitrile: water (75:25%v/v), at a flow rate of 1.5 ml/min and with detection wave length 239 nm. The retention times for citalopram HBr was 5.56 min. The calibration plots were linear over the concentration range of 10-60 μg/ml with regression coefficient of 0.999 for citalopram HBr. Citalopram HBr was subjected to acid and alkali hydrolysis, oxidation, and photo and thermal degradation. The citalopram shows relative high thermal and photo stability. i.e.(0.64% at 48 hours and 0.44% at 72 hours) as compared to other stability conditions. This method was then validated for different parameters as per the international conference for harmonization guidelines (ICH). This HPLC and UV methods can be used for the determination for the stability indicating assay methods for citalopram HBr & its formulations.