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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 1
First page : ( 420) Last page : ( 426)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00076.7

Development and validation a new stability indicating RP-UFLC method for the quantification of Voriconazole

Lingamaneni Kalyani*, Annapurna Mukthinuthalapati Mathrusri

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: kalyani.lingamaneni@gmail.com

Online published on 22 April, 2021.

Abstract

Voriconazole is anti-fungal agent. Voriconazole is used for treating invasive candidiasis, invasive aspergillosis and emerging fungal infections. A new stability indicating RP-UFLC method has been proposed for the quantification of Voriconazole in pharmaceutical formulations and the method was validated as per ICH guidelines. Mobile phase consisting of a mixture of Acetonitrile: 0.01% Acetic acid (50: 50, v/v) (pH 5.0) with a flow rate 1 mL/min and UV detection at 240 nm was used for the assay of Voriconazole. The drug was exposed to different stress conditions such as alkaline, acidic, thermal and oxidation degradation. Linearity was observed over the concentration range 0.5–50 μg/mL with linear regression equation y = 23554x-774.8 (r2 = 0.9999). The LOQ and LOD were found to be 0.3987 μg/mL was found to be 0.1313 μg/mL. The present method can be useful for the quantification of pharmaceutical formulations such as tablets and injections and also for the bioanalytical studies.

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Keywords

Voriconazole, RP-UFLC, Validation, Stability indicating, ICH guidelines.

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