Articles Accepted

DEVELOPMENT, OPTIMIZATION, AND VALIDATION OF HPLC METHOD FOR ASSAY AND DISSOLUTION TESTING OF FUROSEMIDE TABLET FORMULATION UTILIZING THE DESIGN OF EXPERIMENT APPROACH
by Dr. Rashmin Patel, 07 May 2020

A simple, specific, and robust HPLC method has been developed and validated for the quantitative estimation of the Furosemide tablet and dissolution testing. Box-Behnken experimental design was employed in the optimization of chromatographic conditions (% organic phase, flow rate, and pH of aqueous phase). The design of experiment approach was successfully applied for the development of a robust method. The optimized HPLC conditions including Phenomenex Luna C18 (250mm × 4.6 mm, 5µm) column, an isocratic mobile phase consisting of methanol: aqueous solution of formic acid buffer (0.2% v/v, pH 2.5) (60:40 % v/v), flow rate 1.0 mL/min, injection volume 20µL, column oven temperature 25C, detection wavelength of 275 nm and a total run time of 10 min, was found to give Furosemide peak at Rt value 4.86 ± 0.2 min. The optimized method was validated according to ICH Q2(R1) guideline. Robustness of the method was assessed using Fractional Factorial design with six chromatographic factors. The outcomes clearly exhibited an effective application of a multivariant approach to optimize a robust HPLC method for routine quality control of Furosemide in tablet formulations.

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