Development and Validation of a Stability Indicating RP-HPLC Method for Determination of Xanthinol Nicotinate in Bulk and Sustained Release Tablet Dosage Forms
 
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Department of Pharmaceutical Analysis and Quality Assurance, Roland Institute of Pharmaceutical Sciences, Ambapua, Berhampur-760010, Orissa, India
CORRESPONDING AUTHOR
Panda Sagar Suman   

Department of Pharmaceutical Analysis and Quality Assurance, Roland Institute of Pharmaceutical Sciences, Ambapua, Berhampur-760010, Orissa, India
Publish date: 2017-10-06
 
Eurasian J Anal Chem 2009;4(2):168–174
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ABSTRACT
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.
 
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