Method development and validation of a new stability indicating HPLC and LC-ESI-MS/MS methods for the determination of Tavaborole

  • Dipak Chandrakant Kulkarni Department of Chemistry, GITAM School of Science, Visakhapatnam, India
  • Anima Sunil Dadhich Department of Chemistry, GITAM School of Science, Visakhapatnam, India
  • Mukthinuthalapati Mathrusri Annapurna GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

Abstract

Tavaborole, a topical antifungal agent containing Boron is used for the treatment of onychomycosis, an infection of the nail and nail bed caused by Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole is chemically known as 5 - Fluoro -1,3 - dihydro -2,1-benzoxaborol -1-ol. It acts by inhibiting Leucyl-tRNA synthetase an essential fungal enzyme required for protein synthesis. AB SCIEX Instruments LC-ESI-MS/MS (Model no. 5068379-Y) QTRAP Enabled Triple Quad 5500+ with Agilent Zorbox C18 (150 mm x 4.6 mm x 3 µm) column and PDA detector was employed for the present study. The total run time was 10 mins and the detection wavelength was 254 nm. A mixture of 5 mM Ammonium formate: Methanol (30: 70) was used as mobile phase on isocratic mode with 1 ml/min as flow rate. Tavaborole has shown linearity over the concentration range 0.5-100 μg/ml and the proposed method was validated as per ICH guidelines. The proposed method is found to be simple, precise, accurate and suitable for the quantification of the marketed formulations of Tavaborole. Stress degradation studies were performed and the method is found to be selective and specific.


Keywords: Tavaborole, Stability indicating, LC-ESI-MS/MS, Validation.

Keywords: Tavaborole, Stability indicating, LC-ESI-MS/MS, Validation

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Author Biographies

Dipak Chandrakant Kulkarni, Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Anima Sunil Dadhich, Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Department of Chemistry, GITAM School of Science, Visakhapatnam, India

Mukthinuthalapati Mathrusri Annapurna, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

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Kulkarni DC, Dadhich AS, Annapurna MM. Method development and validation of a new stability indicating HPLC and LC-ESI-MS/MS methods for the determination of Tavaborole. JDDT [Internet]. 15Jun.2024 [cited 17Jul.2024];14(6):161-9. Available from: https://jddtonline.info/index.php/jddt/article/view/6642