UV spectrophotometric stability indicating method development and validation for the estimation of 5-fluorouracil in the bulk

For the determination of the 5-fluorouracil in the bulk, a simple, accurate, precise, stability-indicating UV spectrophotometric approach has been established. For determination of 5-fluorouracil HPLC grade water used as a solvent and shows maximum absorbance at 265 nm. The developed approach completed validation for a variety of parameters, such as linearity, precision, accuracy, robustness, ruggedness, LOD, and LOQ. This method followed Beer's law for the concentration range of 4-14 & mu;g/ml for 5-fluorouracil. The recovery testing showed that the suggested approach was accurate and per cent relative standard deviation (%RSD) confirmed this method was precise, robust. Forced degradation studies were performed under acidic, alkali, thermal and oxidative conditions as per ICH guidelines.