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Sci. Pharm. 2011, 79(4), 817-836; doi:10.3797/scipharm.1107-18

Identification of Major Degradation Products of Ketoconazole

1
Sharon Bio Medicine, 312, C-Wing, BSEL Tech Park, Opp. Vashi Railway Station, Sector 30 (A), Vashi, Navi-Mumbai-400703, India
2
Shri Jagdishprasad Jhabarmal Tiberewala University, J. B. Nagar, Andheri (E), Mumbai–400059, India
*
Author to whom correspondence should be addressed.
Received: 14 July 2011 / Accepted: 13 October 2011 / Published: 13 October 2011
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Abstract

Analytical methods were developed for the identification of major degradation products of Ketoconazole, an antifungal agent. The stressed degradation of Ketoconazole drug substance was performed under acid, base, thermal, photo and oxidative stress conditions. The major degradation was observed under acid, base and oxidative stress conditions. The degradation study was performed on Inertsil ODS-3V, length 100 X diameter 4.6 mm, particle size 3 μm column using gradient method. These degradants were identified by LC-MS technique.
Keywords: Ketoconazole; Stress degradation; Hydrolysis degradent; Oxidative degradent; LC-MS Ketoconazole; Stress degradation; Hydrolysis degradent; Oxidative degradent; LC-MS
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

MHASKE, R.A.; SAHASRABUDHE, S. Identification of Major Degradation Products of Ketoconazole. Sci. Pharm. 2011, 79, 817-836.

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