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Stability indicating HPLC method development and validation for simultaneous determination of dimethicone and mosapride in bulk and tablet dosage form | Abstract
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Abstract

Stability indicating HPLC method development and validation for simultaneous determination of dimethicone and mosapride in bulk and tablet dosage form

Author(s): Narottam Pal, A. Srinivasa Rao and P. Ravikumar

The present work is a method development and validation for the simultaneous determination as well as stability studies for the bulk and combined tablet formulation of Dimethicone and Mosapride by using reverse phase High performance liquid chromatography (HPLC) with isocratic elution where the stationary phase used was BDS column (250 mm, 4.6 mm, 5 μm), mobile phase was buffer (Ortho phosphoric acid 0.1%) and Acetonitrile at the ratio of 55:45. pH of the chromatographic system was maintained at 3.0, flow rate 1.2 ml/minute, eluent was monitored by PDA detector wavelength at 274 nm. Retention time was found to be 2.369 minutes and 3.433 minutes, correlation coefficient 0.999 and 0.998, LOD 0.207 and 0.002, LOQ 0.628 and 0.007 for Dimethicone and Mosapride respectively. Linearity range was designed 62.5 μg/ml to 375 μg/ml for Dimethicone and 2.5 μg/ml to 15 μg/ml for Mosapride. Accuracy study revealed percentage recovery 99.7%-100.87% and 100.02%-100.20%, repeatability results in terms of relative standard deviation (%RSD) 0.92 and 1.0 for Dimethicone and Mosapride respectively. The developed method was validated as per ICH guideline and was found to be an ideal one for regular analysis in the laboratory.