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Development and Validation of a Stability Indicating RP-HPLC Method for Determination of Xanthinol Nicotinate in Bulk and Sustained Release Tablet Dosage Forms
[摘要] The present paper deals with the development and validation of a stability indicating reverse phase HPLC method for the determination of Xanthinol nicotinate on Hypersil ODS C18 column (250mm × 4mm,5µm) . A mobile phase consisting of methanol: 0.01M TBAHS (50:50 % v/v) was used.Doxophylline was used as the internal standard.The flow rate was 0.8ml/min..The separation was performed at room temperature.Detection was carried out at 267nm by UV detection.The developed method was statistically  validated for the linearity,accuracy,specificity,LOD and LOQ.The specificity of the method was ascertained by forced degradation studies by acid and alkali degradation,oxidation,photolysis and heat degradation.The degraded products were well separated from the analyte with significant differences in their Retention time values.Beer Law is obeyed over a concentration range of 1-400µg mL-1 and correlation coefficient was 0.9995.
[发布日期]  [发布机构] 
[效力级别]  [学科分类] 分析化学
[关键词] Xanthinol nicotinate;Nicotinic acid;Forced degradation;RP-HPLC [时效性] 
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