Published June 25, 2025 | Version v1

RP-HPLC Method Development and Validation for The Estimation of Citalopram in Bulk and Pharmaceutical Dosage Form

Description

Citalopram was estimated in bulk and pharmaceutical formulations using a reverse phase high performance liquid chromatography method that was developed and validated in this work. Several technique factors, including buffer concentration, mobile phase ratio, and column type, were varied in statistically planned trials to evaluate the impact of these parameters on the chromatographic separation of citalopram. Methanol: Acetonitrile: Potassium Dihydrogen Orthophosphate buffer pH 4.5 in a ratio of 50:40:10 (v/v) was used to perform the separation on an Agilent Eclipse XDB C18 Column (250 x 4.6 mm and 5µm) at room temperature under isocratic conditions at a flow rate of 1.0 mL/min. A UV detector operating at 245 nm for a total of 8 minutes made the detection. In the concentration range of 10–35 μg/mL, calibration curves were linear. The developed method's sensitivity is demonstrated by the observed LOD of 1.213μg/mL and the calculated LOQ of 3.129μg/mL. The method's robustness and ruggedness were confirmed by the %RSD being less than 2. In formulation analysis, the assay percentage was 98.95. As a result, citalopram in pharmaceutical formulations and bulk drug was routinely analysed using this technology

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86-Research paper-Narasimha Rao B. V.pdf

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