Development and Validation of Stability Indicating Method of UV-Spectrophotometry for the Estimation of Flavoxate in Bulk and Tablet Dosage form

Abstract

Literature survey reveals that few spectrophotometric, high performance liquid chromatographic (HPLC) and High Performance Thin Layer Chromatographic (HPTLC) methods were reported for the estimation of Flavoxate HCl in single and in combined dosage forms. But there is no any stability indicating UV spectroscopic study is reported for Flavoxate in single dosage form. So the present study was aimed to development of simple, accurate, rapid and economical UV-spectrophotometric stability indicating assay method were established for the determination of Flavoxate HCl in bulk and tablet formulation. The solvent was selected for stock solution preparation is water and required concentrations were prepared by using the same solvent. The λmax for detection of Flavoxate HCl is 211nm. In this method Flavoxate followed linearity in the concentrations of 1, 3, 5, 7, 9µg/ml with regression coefficient (r2) 0.999. The percent drug content was found to be 98.81±0.39 for FLV in tablet formulation. Recovery study results of FLV ranges from 99.11 to 100.49%. The method was found to be accurate and precise, as indicate by recovery studies as recoveries were close to 100% and %RSD is less than 2. Inter-day and intraday variation was found to be 0.75 and 0.45%, respectively. The LOD and LOQ values were found to be 0.719µg/ml and 2.186µg/ml, respectively. The stability study of Flavoxate was investigated when the drug was subjected to hydrolytic, peroxide, heat and photolytic (UV and sunlight) degradation. The results express that the Flavoxate is under thermal and photolytic (sunlight and UV light) conditions are more stable. In acidic, basic and hydrogen peroxide conditions Flavoxate is degraded in higher amount.