RP-HPLC ANALYTICAL METHOD DEVELOPMENT, FORMULATION AND EVALUATION OF ENTERIC COATED TABLETS OF PACLITAXEL USED AS BIO-ENHANCER

Abstract

An easy, fast and validated RP-HPLC method was invented to quantify paclitaxel in drug solution and orally disintegrating tablet. The separation was carried out using reversed phase C-18 column (Agilent Eclipse Plus C-18) with UV detection at 268 nm. Method optimization was tested using various compositions of organic solvent. The mobile phase comprised of phosphate buffer (0.01M), methanol and acetonitrile (50:30:20, v/v) adjusted to pH 2.7 with phosphoric acid (80%) was found as the optimum mobile phase. The method showed intraday precision and accuracy in the range of 0.24% to -1.83% and -1.83% to 1.99% respectively. The standard calibration curve was linear from 0.125μg/mL to 16μg/mL. In formulation development, five different tablets were prepared as shown in table with constant amount of quercetin but varying concentration of mannitol, calcium phosphate etc. Disintegration studies, observed that F1 as per table shows the best disintegration time of 1.5±0.20 min. This formulation was further chosen for the enteric coating. Formulation evaluations were found to be bulk density; 0.45±0.02 g/cc and tapped density 0.53±0.01 g/cc. The angle of repose was found to be 29.16±0.82 θ and Carr’s Index was found to be 18.26±0.25. Hardness was found to be 5.1±0.41 kg/cm2 and friability was found to be 0.19 ± 0.01%. To confirm the equal distribution of the weight the weight variation was tested which was found to be 199.16±2.36. This parameter confirms the granules are good in physical properties and can be used further for compression. The drug solution was stable under room temperature at least for 6 hours.