Development and Validation of RP-HPLC Method for Simultaneous Quantification of Tavaborole, Hydrocortisone, and Clindamycin Phosphate in Pharmaceutical Dosage Forms

Abstract

This study introduces a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for concurrently quantifying Tavaborole, Hydrocortisone, and Clindamycin phosphate in diverse pharmaceutical formulations, including topical solutions, creams, and gels. The method employs the use of mobile phase involving 10 mM Ammonium acetate and Acetonitrile with Acetic acid, offering a sensitive and cost-effective approach. Validation studies demonstrate the method's accuracy, precision, and robustness, rendering it suitable for comprehensive analysis of combined dosage forms. Utilizing a Unisphere C18 column along with UV absorption detection at 225 nm, the analysis reveals retention times of 3.1 minutes for CLN, 5.1 minutes for HYN, and 6.1 minutes for TVB. The method exhibits excellent percentage recoveries for all compounds, ranging from 96% to 99%. Extensive validation includes assessments of linearity, selectivity, recovery, repeatability, LOD/LOQ values, and suitability in topical solution, cream, and gel placebo formulations. This cost-effective technique enables simultaneous and precise quantification of Tavaborole alongside Hydrocortisone and Clindamycin phosphate in various pharmaceutical compositions, underscoring its significance as a dependable tool for quality assurance and pharmaceutical research, offering both accuracy and efficiency.