Abstract:
A simple, sensitive and precise high performance liquid chromatographic (HPLC) method was developed and
validated for determination of flavoxate HCI in raw material, tablets and biological fluids. The method followed by using
the Zorbax XDB-C18 column containing Di-isobutyl n-octadeceylsilane (4.6mm×150mm, 5μm). The mobile phase
consisted of acetonitrile: methanol: 0.15M sodium perchlorate (17:35:48 v/v) having pH 3. UV detection was carried out
at 229nm at 40°C. Results indicated that the method has successfully established and validated in accordance with ICH
guidelines acceptance criteria for linearity (0.03-7.5µg), accuracy (101.18-101.28%), robustness of column age and
column lot (peak area %CV≤0.04, purity %CV≤ 0.006) and robustness of HPLC condition (%CV≤ 0.02), precision (intra
and inter day precision assay, %CV values for peak area and percent purity of flavoxate HCl≤2%) and system suitability
parameters. The average noise, theoretical LOD and LOQ were found to be 0.01 mAU, 0.03 mAU and 0.6ng,
respectively. The Coefficient of determination (r2
) ranging from 0.03µg to 7.5µg, 0.99 which was within acceptable
criteria of r2 & gt 0.99. The spiked recoveries of samples were 101.28, 101.18 and 101.18% respectively. All data
revealed that this method can be used for in-vitro & in-vivo determination of flavoxate HCI in various pharmaceutical
preparations.
