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Development and validation of stability indicating RP-HPLC method for voriconazole

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Author(s): Khetre A | Sinha P | Damle Mrinalini | Mehendre R

Journal: Indian Journal of Pharmaceutical Sciences
ISSN 0250-474X

Volume: 71;
Issue: 5;
Start page: 509;
Date: 2009;
Original page

Keywords: RP-HPLC | stability indicating | validation | voriconazole

ABSTRACT
This study describes the development and validation of stability indicating HPLC method for voriconazole, an antifungal drug. Voriconazole was subjected to stress degradation under different conditions recommended by International Conference on Harmonization. The sample so generated was used to develop a stability-indicating high performance liquid chromatographic method for voriconazole. The peak for voriconazole was well resolved from peaks of degradation products, using a Hypersil C18 (250Χ4.6 mm) column and a mobile phase comprising of acetonitrile: water (40:60, v/v), at flow rate of 1 ml/min. Detection was carried out using photodiode array detector. A linear response (r > 0.99) was observed in the range of 5-25 μg/ml. The method showed good recoveries (average 100.06%) and relative standard deviation for intra and inter-day were ≤ 1.5 %. The method was validated for specificity and robustness also.
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