DefinePK

Abstract

The objective of this study was to create a straightforward, precise, and advanced method for simultaneous measurement of benzyl alcohol (BA) and efinaconazole (EFI) in topical formulations using reverse-phase high-performance liquid chromatography (RP-HPLC) with an Inertsustain C18 column (250 × 4.6 mm, 5 µm). The mobile phase comprised a blend of methanol and buffer-30mM ammonium dihydrogen phosphate (pH 3.00) in a 65:35 ratio, with a flow rate of 1.5 ml/min. The elution was observed at 210 nm. The technique showed linearity within concentration spans of 40–300μg/ml for EFI (R² = 0.99992) and 16–120μg/ml for BA (R² = 0.99996). The limits of detection for EFI and BA were determined to be 507.49ng/ml and 2838.43ng/mL, respectively, whereas the limits of quantification were 1.54μg/ml for EFI and 8.60μg/ml for BA. The method's validation was conducted following ICH guidelines, achieving accuracy between 98.0% and 102.0%. Both intra-assay and inter-assay precision demonstrated a coefficient of variation under 2.0%. The strength of the created analytical method was further examined by making slight adjustments in wavelength and flow rate. The results from robustness studies indicated that the relative standard deviation and percentage recovery for both BA and EFI fell within the acceptance criteria outlined in the ICH Q2 (R1) guidelines. The established method was exact, dependable, and reliable for concurrent measurement of EFI and BA in pharmaceutical formulations, confirming its suitability for regular analysis.