Development and Validation of a New RP-HPLC Method for Simultaneous Estimation of Butenafine Hydrochloride and Curcumin in Bulk and Pharmaceutical Dosage Form

A new, simple and sensitive reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous quantitative determination of Butenafine hydrochloride (BUT) and Curcumin (CUR) in bulk and combined pharmaceutical dosage form. Such a method is required for routine quality control of emerging topical formulations containing this antifungal–anti-inflammatory pair. Chromatographic separation was achieved on a C18 column (250 × 4.6 mm, 5 µm) column using a mobile phase consisting of Methanol: Water (90:10 v/v) at a flow rate of 1.0 mL/min with isocratic elution. Detection was performed at 254 nm. The method was validated in accordance with ICH guidelines for specificity, linearity, accuracy, precision, limits of detection (LOD) and limit of quantitation (LOQ), robustness and solution stability. Well-resolved peaks of BUT and CUR were obtained with retention times of approximately 10.5 min and 1.8 min, respectively. The method showed excellent linearity over the concentration ranges of 5-15 µg/mL for BUT and CUR with correlation coefficients (r²=0,9967 and r²= 0,9976). Mean recoveries were within 98–102 % for both analytes, and intra- and inter-day precision values were below 2% RSD. The calculated LODs and LOQs indicated high sensitivity, and no interference from formulation excipients was observed. The proposed RP-HPLC method is simple, rapid, specific, accurate and precise, and is suitable for routine quality control analysis of BUT and CUR in bulk materials and combined pharmaceutical dosage forms.