European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD OF RP-HPLC FOR QUANTIFICATION OF TAVABOROLE RELATED SUBSTANCES: APPLICATION TO 5% TOPICAL SOLUTION

Siva Rao Tirukkovalluri*, Venu Balireddi and Krishna Murthy Tatikonda

ABSTRACT

Novel stability indicating analytical method development for estimation of Tavaborole related substances such as Known and Unknown impurities in antifungal Drug product of 5% Topical solution. The optimum separation was achieved on reverse phase HPLC reverse phase column (250 mm X 4.6 mm, 3 μm) with Perchloric acid (TFA), methanol and acetonitrile as mobile phase using simple gradient elution technique, and with UV detection analysis which can helps in quantification of impurities during shelf life. All impurities were separated with good resolution and preparation of Tavaborole was exposed to various environments like acid treatment, alkali treatment, peroxide treatment, photo, thermal irradiation and injected in the developed analytical method to assess the stability indicating nature. Detection was monitored using PDA detector, this method was found to be sensitive, precise, and accurate with detection limit is below 0.02μg/mL, limit of quantification 0.05μg/mL for all its impurities.

Keywords: Tavaborole, Related substances, Method development, HPLC, stability, Topical solution.