METHOD DEVELOPMENT AND VALIDATION OF NITROFURANTOIN BY COLORIMETRY USING PDAB REAGENT

Abstract

In the present research, a sensitive, simple, rapid and accurate analytical method for the colourimetric estimation of Nitrofurantoin in formulations has been developed and validated using chemical reagents by visible colourimetry. Different aliquots of Nitrofurantoin in solvent and PDAB were prepared in the concentration range of 35– 100  g/ml and the absorbances of solutions were measured at 407nm. The optical parameters like, Sandell’s sensitivity, Molar absorptivitys, correlation coefficient, slope, intercept, LOD, LOQ and Standard error were calculated for the drug. The correlation coefficient for the two drugs was found to be 0.999. The % RSD values of intraday and interday analysis were found to be 0.96551, and 0.965514. The low % RSD values indicate that the developed method was more rugged. The accuracy of the method was confirmed by recovery studies. The percentage recovery was found to be in the range of 100.45 – 99.92% for Nitrofurantoin. The proposed method was applied to the determination of certain pharmaceutical dosage forms containing the nitro-compounds. The results obtained were in agreement with those obtained by official and compendium methods and validated according to ICH guidelines.