New spectrophotometric methods have been established for the determination of Tavaborole in pharmaceutical formulations. Tavaborole is an antifungal agent used for the fungal infection of nail (onychomycosis). Tavaborole is chemically known as 5 - Fluoro -1,3 - dihydro -2,1-benzoxaborol -1-ol. Tavaborole has shown absorption maxima at 271 nm in all the methods. A calibration curve was drawn by taking the concentration on the X – axis and their respective absorbance on Y – axis for all the methods. Tavaborole obeys Beer-Lambert’s law over the concentration range 1-100µg/ml for all the above mentioned methods. The linear regression equations were found to be y = 0.0049x + 0.0017(R² = 0.9999) and all the methods are validated as per ICH guidelines.
Cite this article:
Avuthu Sai Sheela, Mukthinuthalapati Mathrusri Annapurna, Rangisetty Spandana Yasaswini. New validated analytical methods for the determination of Tavaborole (An anti-fungal agent). Research J. Pharm. and Tech. 2020; 13(4):1893-1898. doi: 10.5958/0974-360X.2020.00341.8
Avuthu Sai Sheela, Mukthinuthalapati Mathrusri Annapurna, Rangisetty Spandana Yasaswini. New validated analytical methods for the determination of Tavaborole (An anti-fungal agent). Research J. Pharm. and Tech. 2020; 13(4):1893-1898. doi: 10.5958/0974-360X.2020.00341.8 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-4-51
1. Toledo-Bahena ME, Bucko A, Ocampo-Candiani J, Herz-Ruelas ME, Jones TM, Jarratt MT, Pollak RA, Zane LT: The efficacy and safety of Tavaborole, a novel, boron-based pharmaceutical agent: Phase 2 studies conducted for the topical treatment of toenail onychomycosis. J Drugs Dermatol. 2014; 13(9): 1124-1132.
2. Boni EE, Raza Aly, Sheryl LB et al., Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies". Journal of the American Academy of Dermatology. 2015; 73 (1): 62–69.
3. Markham A: Tavaborole: first global approval. Drugs 2014 Sep; 74(13): 1555-58.
4. Siva Rao T, Venu Balireddi and Krishna Murthy T. Analytical method development and validation of stability indicating method of RP-HPLC for quantification of Tavaborole related substances: Application to 5% topical solution. European Journal of Biomedical and Pharmaceutical Sciences, 2018; 5(9): 545-550.
5. Tampucci Silvia, Terreni Eleonora, Burgalassi Susi, Chetoni Patrizia, Monti Daniela. Development and Validation of an HPLC-UV Method to Quantify Tavaborole During in Vitro Transungual Permeation Studies. Journal of AOAC International, 2018; 101(2): 437-443.
6. ICH Q2 [R1] validation of analytical procedures: Text and Methodology: November 2005.