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Development and Validation of Stability Indicating RP-HPLC Method for Voriconazole
A B Khetre1, P K Sinha, Mrinalini C Damle
1Department of Pharmaceutical Chemistry, AISSMS College of Pharmacy, Pune-411 001, India.
Indian Journal of Pharmaceutical Sciences
|May 27, 2010
Summary
A new stability-indicating HPLC method was developed for voriconazole, an antifungal drug. This validated method effectively separates voriconazole from its degradation products, ensuring drug quality.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Voriconazole is a crucial antifungal medication.
- Ensuring the stability and purity of voriconazole is vital for patient safety and effective treatment.
- Existing analytical methods may not adequately assess voriconazole degradation.
Purpose of the Study:
- To develop and validate a stability-indicating High-Performance Liquid Chromatography (HPLC) method for voriconazole.
- To ensure the method can accurately quantify voriconazole in the presence of its degradation products.
Main Methods:
- Voriconazole was subjected to stress degradation under International Conference on Harmonization (ICH) recommended conditions.
- A stability-indicating HPLC method was developed using a Hypersil C18 column and a mobile phase of acetonitrile:water (40:60, v/v).
- Detection was performed using a photodiode array detector.
Main Results:
- The developed HPLC method demonstrated excellent resolution between voriconazole and its degradation products.
- A linear response was observed in the concentration range of 5-25 µg/ml (r > 0.99).
- The method exhibited high accuracy (average recovery 100.06%) and precision (RSD ≤ 1.5% for intra- and inter-day assays).
Conclusions:
- The developed stability-indicating HPLC method is suitable for the analysis of voriconazole.
- The method is validated for specificity and robustness, confirming its reliability for quality control.
- This analytical tool is essential for assessing the stability and ensuring the quality of voriconazole formulations.
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