title: Development and validation of dissolution study of sustained release dextromethorphan hydrobromide tablets.
abstract: This study describes the development and validation of dissolution tests for sustained release Dextromethorphan hydrobromide tablets using an HPLC method. Chromatographic separation was achieved on a C18 column utilizing 0.5% triethylamine (pH 7.5) and acetonitrile in the ratio of 50:50. The detection wavelength was 280 nm. The method was validated and response was found to be linear in the drug concentration range of 10-80 microg mL(-1). The suitable conditions were clearly decided after testing sink conditions, dissolution medium and agitation intensity. The most excellent dissolution conditions tested, for the Dextromethorphan hydrobromide was applied to appraise the dissolution profiles. The method was validated and response was found to be linear in the drug concentration range of 10-80 microg mL(-1). The method was established to have sufficient intermediate precision as similar separation was achieved on another instrument handled by different operators. Mean Recovery was 101.82%. Intra precisions for three different concentrations were 1.23, 1.10 0.72 and 1.57, 1.69, 0.95 and inter run precisions were % RSD 0.83, 1.36 and 1.57%, respectively. The method was successfully applied for dissolution study of the developed Dextromethorphan hydrobromide tablets.
authors.forename: Sekar
authors.initials: S
authors.lastname: Rajan
authors.forename: Socorrina
authors.initials: S
authors.lastname: Colaco
authors.forename: N
authors.initials: N
authors.lastname: Ramesh
authors.forename: Subramania Nainar
authors.initials: SN
authors.lastname: Meyyanathan
authors.forename: K
authors.initials: K
authors.lastname: Elango
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003692:Delayed-Action Preparations / Q000032:analysis / Q000737:chemistry; D003915:Dextromethorphan / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry*; D016014:Linear Models; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012995:Solubility; D013607:Tablets / Q000737:chemistry / Q000592:standards
chemical_list: D003692:Delayed-Action Preparations; D013607:Tablets; D003915:Dextromethorphan