Quality by Design Approach for Development and Validation of Analytical Method for Estimation of Furosemide in Bulk and Formulation
Abstract
Background: A common loop diuretic used to manage edema, CHF, and hypertension is furosemide. The majority of described HPLCtechniques for its estimation are linked to longer run times and higher solvent consumption, and they lack a systematic Quality byDesign (QbD) approach. Objectives: Using a QbD methodology, the current work sought to design and validate a reliable, quick, and economical HPLC techniquefor furosemide quantification in pharmaceutical formulations and bulk. Materials and Methods: A central composite design was used to improve crucial procedure parameters like flow rate and mobile phasecomposition. Chromatographic separation was carried out using a column C18 with acetonitrile and 0.1% OPA (70:30 v/v) as the mobilephase at a flow rate 0.8 mL/min and detection at 277 nm. In compliance with ICH Q2(R1) standards, the developed method was verifiedfor linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ. Results: With a correlation coefficient (R2) of 0.9994, the method show outstanding linearity over the range of 5–30 ppm. Precision studiesindicated %RSD values below 2%, while accuracy studies showed recovery between 98–102%. It was discovered that the approachwas strong and resilient, with little change under various circumstances instruments. The results showed that the LOD and LOQ were0.65 μg/mL and 1.97 μg/mL, respectively. Summary: The new QbD-based RP-HPLC method is simple, precise, and appropriate for routine quantitative analysis of furosemide inbulk and medicinal dose forms.
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