Simultaneous Development and Validation of an HPLC Method for the Determination of Furosemide and Its Degraded Compound in Pediatric Extemporaneous Furosemide Oral Solution.

Furosemide (FUR) is a loop diuretic widely used in pediatric care. However, no standardized oral liquid formulation exists due to degradation concerns, particularly the formation of furosemide-related compound B (FUR-B). This study aimed to develop and validate the HPLC method for the simultaneous quantification of FUR, FUR-B, methylparaben (MP), and propylparaben (PP) in pediatric extemporaneous oral solutions. Chromatographic separation was achieved using a Symmetry^® C18 column (4.6 × 250 mm, 5 µm) with a mobile phase of 0.1% acetic acid in water and acetonitrile (60:40, v/v) at 1.0 mL/min of flow with injection volume at 10 µL. Detection at 272 nm provided optimal sensitivity, especially for low concentrations of FUR-B. Forced degradation confirmed baseline separation of FUR from its degradation products. The condition showed high linearity (R² > 0.995), accuracy (recoveries 98.2-101.0%), and precision (RSD ≤ 2%). Robustness and ruggedness tests under varied conditions, analysts, and intra-day yielded consistent performance. Application to extemporaneous formulations showed that refrigeration (2-8 °C) retained initial composition, while elevated temperatures (30 °C and 40 °C) promoted FUR degradation, with FUR-B increasing to 6.84% after 90 days and greater MP and PP degradation. This validated method offers a reliable analytical tool for monitoring chemical changes and supporting quality control of pediatric FUR extemporaneous formulations.