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Sci. Pharm. 2011; 79: 817–836

Identification of Major Degradation Products of Ketoconazole

Rajendra A. MHASKE * 1, Shirish SAHASRABUDHE 2

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.

* Corresponding author. E-mail: (R. A. Mhaske)


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.


Ketoconazole • Stress degradation • Hydrolysis degradent • Oxidative degradent • LC-MS

Received July 14th, 2011 | Accepted October 13th, 2011 | Published Online October 13th, 2011