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Validation and Development of New RpHPLC Methods of Levosulphiride Pellets

Abstract

Sandeep Rajan Kolli, K.Mohini Kalyani, P.Uday Bhaskar, K.Vineela

A simple, economic, selective, precise, Reverse phase High Performance Liquid Chromatography method for analysis of levosulphride pellets 40%, was developed and validated according to ICH guidelines. The quantification of the drug was carried out using grace smart, 250mm × 4.6mm × 5μm or its equivalent in isocratic mode, with mobile phase compressing of Buffer : Acetonitrile (70:30) The flow rate was 0.8ml/min and the detection was carried out by PDA detector i.e., 237 nm. The retention time for levosulphride pellets was found to be 2.3 min. The percent assay was found to be 98.98%. The method of levosulphride pellets validated for precision, accuracy, linearity range, specificity and robustness.

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