DISSOLUTION METHOD DEVELOPMENT AND VALIDATION OF ACAMPROSATE CALCIUM TABLETS BY UV SPECTROPHOTOMETRY

The article aims at developing simple dissolution method for Acamprosate calcium immediate enteric coated tablets by UV spectroscopy and validate as per ICH guidelines. The optimized dissolution method includes stage 1 as 0.1N HCl as dissolution media, apparatus: USP Type 2 Paddle, rpm: 100, temperature of dissolution media: 37±0.5ºC, dissolution volume: 900ml, dissolution time point: 2 hours and stage 2 as dissolution media: water, apparatus: USP Type 2 Paddle, rpm: 100, temperature of dissolution media: 37±0.5ºC, dissolution volume: 900ml, dissolution time point: 2 hours and working concentration of standard and sample as 100?g/ml at a detection wavelength of 210nm.The developed method resulted in Acamprosate calcium exhibiting linearity in the range 25-200μg/ml. System precision and intra-day precision are exemplified by relative standard deviation of 1.197% and 3.37% respectively. Method was found to be rugged/inter day precise as %RSD was found to be 3.75%. Percentage Mean recovery was found to be in the range of 90-110 % by absolute method during accuracy studies. The limit of detection (LOD) was found to be 10 ?g/mL for Acamprosate calcium and limit of quantitation (LOQ) was found to be 31 ?g/mL for Acamprosate calcium. Hence it can be concluded that effective dissolution method by UV spectroscopy is developed and validated as per ICH guidelines which can be applicable in various pharmaceutical industries. Keywords: Acamprosate calcium, Dissolution method, UV, Validation