Abstract

METHOD DEVELOPMENT & VALIDATION OF ACAMPROSATE TABLET DOSAGE FORM BY RP-HPLC

Meruga Aseervadamma*, CH. Ajay Babu, K.V.Ramanjaneyulu, J.N.Suresh Kumar, Mahaboob Basha.

ABSTRACT

Objective: To develop a cheap, accurate, precise, linear and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Acamprosate calcium (333 mg) in tablets. Methods: The optimized method uses a reverse phase column (250 X 4.6 mm; 5μ), a mobile phase of 0.2M Ammonium acetate: Acetonitrile (40:60 v/v) flow rate of 0.5 ml/min and a detection wavelength of 220 nm using a UV detector. Results: The developed method resulted in Acamprosate calcium eluting at 4.187 min. Acamprosate calcium exhibited linearity in the range 5 - 30 μg/ml. The precision is exemplified by relative standard deviation of 1.02 %. Percentage Mean recovery was found to be in the range of 98.9‐101.2 %, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 0.027μg/ml and 0.082 μg/ml respectively. Conclusion: A cheap, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the quantitative estimation of Acamprosate calcium 333 mg in tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.

Keywords: RP?HPLC, Acamprosate calcium, Method development, Validation.