PHARMANEST : AN INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACEUTICAL SCIENCES - Volume 4, Issue 6, November - December 2013

Pages: 1558-1568

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RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF ZILEUTON IN BULK DRUG AND PHARMACEUTICAL FORMULATIONS

Author: M.MOUSAMI*, A.KRISHNAMANJARI PAWAR, D.V.V. RAMA RAJU

Category: Pharmaceutical Sciences

Abstract:

Zileuton is an antiasthmatic durg. It acts by inhibiting 5-lipoxygenase enzyme thereby preventing formation of leukotrienes that cause bronchoconstriction. The new, simple, accurate, sensitive robust, reproducible, isocratic RP-HPLC method was developed using Xterra C 18 column (5µm, 250 × 4.6mm), at 1ml/min flow rate with 10min run time using 20µl injection volume and 25°C temperature conditions. The detection wavelength used is 299.5nm. Retention time is obtained at 3.155min. Linearity was established in the range of 2 to 10µg/ml with 0.999 correlation coefficient and % recovery of 99.6 – 99.9%. The method is validated according to the specifications in ICH guidelines.

Keywords: Zileuton, RP-HPLC, isocratic mode.