DEVELOPMENT, OPTIMIZATION AND VALIDATION OF HPLC METHOD FOR ASSAY AND DISSOLUTION TESTING OF FUROSEMIDE TABLET FORMULATION UTILIZING DESIGN OF EXPERIMENT APPROACH

Abstract

A robust HPLC method was developed and validated for the quantitative estimation of furosemide tablet and dissolution testing. The optimization of chromatographic conditions (% organic phase, flow rate and pH of aqueous phase) was done using the Box-Behnken experimental design. The creation of a reliable HPLC technique utilised the design of experiments methodology effectively. The furosemide peak was found to have a Rt value of 4.86 min under the optimal HPLC settings, which included a C18 (250 mm 4.6 mm, 5 m) column and a methanol: aqueous solution of formic acid buffer (0.2 % V/V, pH 2.5) as mobile phase.The optimized method was validated according to ICH Q2(R1) guideline. Using a fractional factorial design with six chromatographic components, the robustness of the approach was evaluated. The results showed that a multivariant approach was successfully used to improve a reliable HPLC technique for everyday quality monitoring of furosemide in tablet formulations