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Validated LC Method for the Estimation of Voriconazole in Bulk and Formulation
C N Patel1, J B Dave, J V Patel
1Department of Pharmaceutical Chemistry, Shri Sarvajanik Pharmacy College, Near Arvind Baug, Mehsana-384 001, India.
A new reversed-phase high-performance liquid chromatography method accurately quantifies voriconazole in bulk and formulations. This validated method ensures reliable quality control for voriconazole (VRC) drug products.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Voriconazole (VRC) is a critical antifungal agent requiring precise quantification.
- Accurate analytical methods are essential for quality control of VRC bulk and formulations.
Purpose of the Study:
- To develop and validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for voriconazole estimation.
- To ensure the method's suitability for quality control applications in pharmaceutical formulations.
Main Methods:
- Utilized reversed-phase high-performance liquid chromatography (RP-HPLC) with a diode array detector.
- Employed a mobile phase of water:acetonitrile (35:65 % v/v) and a detection wavelength of 256 nm.
- Validated the method according to International Council for Harmonisation (ICH) guidelines.
Main Results:
- Achieved a linearity range of 0.1 to 2 µg/mL with a regression coefficient (R²) of 0.999.
- Determined the detection limit (LOD) at 0.026 µg/mL and the quantitation limit (LOQ) at 0.1 µg/mL.
- Demonstrated excellent intra-day and inter-day precision and accuracy for voriconazole quantification.
Conclusions:
- The developed RP-HPLC method is accurate, precise, and robust for voriconazole determination.
- This method is suitable for routine quality control of voriconazole in bulk and pharmaceutical formulations.
- The method effectively quantifies voriconazole without interference from common pharmaceutical excipients.
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