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

Author(s): AB Khetre1, PK Sinha1, Mrinalini C Damle1, R Mehendre2
1 Department of Pharmaceutical Chemistry, AISSMS College of Pharmacy, Pune-411 001, India 2 Alkem Laboratories Ltd., Navi Mumbai-410 208, India

Correspondence Address:
Mrinalini C Damle Department of Pharmaceutical Chemistry, AISSMS College of Pharmacy, Pune-411 001 India

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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