NOVEL AND VALIDATED SPECTROPHOTOMETRIC DETERMINATION OF BUDESONIDE FROM BULK AND TABLETS USING MIXED HYDROTROPIC SOLUBILIZATION TECHNIQUE

A novel, safe, accurate, sensitive and economic Spectrophotometric method was developed by application of mixed hydrotropy using  solution containing 45% urea and 5% sodium citrate as hydrotropic solubilizing agent for the quantitative determination of poorly water-soluble budesonide from bulk and tablet dosage form. The solubility of budesonide increases more than 20 times in mixed hydrotropic solution as compared to solubility in distilled water, thus, a mixed hydrotropic solution containing 45% urea and 5% sodium citrate was employed to carry out spectrophotometric analysis precluding use of organic solvents. Budesonide obeyed Lambert Beer’s law in the concentration range of 5 to 30μg/ml (r²= 0.999) in mixed hydrotropic agent with mean recovery was found 98.75±0.63%. The percent concentration in marketed tablet formulation was found 98.56±1.070%. Parameters such as linearity, precision, accuracy, specificity and robustness were studied as reported in the International Conference on Harmonization guidelines. The relative standard deviations for three replicate measurements in five concentrations of samples were always less than 2%. So this method can successfully employ in the routine analysis of budesonide in bulk drug and tablet dosage forms.