METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF ACAMPROSATE CALCIUM IN TABLETS USING RP-HPLC
Objective: To develop an accurate, precise and linear 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, Enable Make C18G (250 X 4.6 mm; 5Î¼), a mobile phase of triethylammonium phosphate buffer (pH 3.0): acetonitrile in the proportion of 30:70 v/v, flow rate of 1.0 ml/min and a detection wavelength of 210 nm using a UV detector.
Results: The developed method resulted in Acamprosate calcium eluting at 2.36 min. Acamprosate calcium exhibited linearity in the range 75-225Î¼g/ml. The precision is exemplified by relative standard deviation of 0.149%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 570 ng/ml and 1729 ng/ml respectively.
Conclusion: An accurate, precise and linear 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 routine analysis in various pharmaceutical industries.
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