Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ILAPRAZOLE IN PHARMACEUTICAL DOSAGE FORMS

Shital S. Patil, Sheetal V. Patil, Rupali S. Wagh, Dr. S.D. Barhate

Abstract

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the estimation of Ilaprazole in pharmaceutical dosage form. Chromatographic separation was carried out by using Hypersil BDS C18 (4.6 x 250 mm) column using a mobile phase consisting of a mixture of Methanol: Water 70:30 pH-3.0 with anhydrous disodium hydrogen phosphate buffer by using an isocratic elution. The following system conditions were maintained throughout development and validation i.e., flow rate 1.0 ml/min, column was maintained at room temperature and the detected by a UV wavelength 237 nm. The Ilaprazole was well resolved and detected at 237nm with retention time 4.4 minutes. Ilaprazole was shown to be linear over a range of 5-25 μgm/ml. The method was validated as per ICH guidelines.

Keywords: Ilaprazole, RP-HPLC, Method validation and C18 Column. W