Development and Validation of a Stability Indicating RP-HPLC Method for Determination of Xanthinol Nicotinate in Bulk and Sustained Release Tablet Dosage Forms

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: 0.01mol.L-1 TBAHS (50:50 % v/v) was
used.Doxophylline was used as the internal standard. The flow rate was 0.8mL min-1.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.