Development and validation of a reversed-phase high-performance liquid chromatographic method for estimation of butenafine hydrochloride in bulk and nanolipid gel

This investigation presents a rapid, sensitive, and accurate RP-HPLC methodology for the quantification of Butenafine HCl within nanolipid gel formulations. Chromatographic resolution was achieved using an HPLC 3000 binary gradient System with a Cosmosil C18 column maintained at 30°C. The optimized mobile phase comprised a mixture of methanol and water, with the pH adjusted at 3.0 using ortho-phosphoric acid. Analysis was performed at a flow rate of 0.8 mL/min, with detection at 283 nm. Butenafine HCl consistently exhibited a retention time of exactly 5.08 minutes. This method demonstrated adequate sensitivity with limits of detection and quantitation suitable for routine pharmaceutical quality control applications. Results confirmed the method's robustness and reliability. Application of this validated method revealed a high BFH content of 99.84 ± 0.21% in the novel nanolipidgel, which is consistent with the 99.93 ± 0.15% observed in a leading commercial preparation. Ultimately, this developed methodology exhibits linearity, precision, and reproducibility, thereby positioning it as an analytical tool for the estimation of BFH across both conventional and pharmaceutical matrices.