Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC in Pharmaceutical Dosage Forms

The purpose of this study is Acamprosate Calcium synthesis of 3-Aminopropane-1-sulfonic acid (Homotaurine) and validation of assay test in the delayed-release tablets by HPLC without organic solvents. The assay method by HPLC was found to be linear in the concentration range of 50 to 200 µg/mL. Successful separation was achieved by isocratic elution on a Phenomenex® C18 column (250 mm × 4.6 mm, 5μm).The mobile phase was triethylammonium phosphate buffer pH: 4.0 (100%) at the flow rate of 1 mL/min using UV detection at 210 nm, column oven temperature 25ºC and injection volume 20 𝜇L. The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.36-100.60%. The LOD and LOQ were found to 0.012 μg/mL and 0.042 μg/mL. All the parameters of validation were in the acceptance range. This developed method was successfully applied for estimate the amount of Acamprosate Calcium in the tablets.