Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2021
  • Volume: 14
  • Issue: 9

A new Validated Stability Indicating RP-UFLC Method for the Estimation of Voriconazole in presence of internal standard

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh - 530045, India

*Corresponding Author E-mail: paladuguvenkatanaveen@gmail.com

Online Published on 22 February, 2022.

Abstract

Voriconazole is used for the treatment of variety of fungal infections caused by aspergillosis, candidiasis, coccidioidomycosis, histoplasmosis, penicilliosis etc. Voriconazole belongs to triazole class. Voriconazole is mainly used to treat certain patients who are not responding to other anti-fungal drugs. It works by slowing the growth of the fungi that cause infection. A new validated reverse phase stability indicating liquid chromatographic method has been developed for the assay of Voriconazole in presence of an internal standard (Rufinamide) tablets. Forced degradation studies were performed to define the selectivity and specificity of the method. Linearity was observed over the concentration range 1.0–100μg/mL with linear regression equation y = 0.4489x – 0.1262 (r2 = 0.9999). The LOQ and LOD were found to be 0.8934μg/mL and 0.2921μg/mL. The present stability indicating RP-UFLC method was validated as per ICH guidelines and can be useful for the assay of tablets and injections and also for the kinetic studies.

Keywords

Voriconazole, RP-UFLC, Rufinamide, Internal standard, Validation, Stability indicating, ICH guidelines