Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF ILAPRAZOLE

Chavda D.*, Bhut P., Chotaliya M., Korat R., Sangani A., Sinhar M., Gandhi M.

ABSTRACT

This study describes the development and validation of stability indicating HPLC method for Ilaprazole, an antiulcer drug. Ilaprazole 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 Ilaprazole. The peak for Ilaprazole was well resolved from peaks of degradation products, using a ODS ECLIPSE XDB- C8(250 mm X 4.6 mm X 5 μm) column and a mobile phase comprising of Acetonitrile: buffer: methanol (40:46:14, v/v), at flow rate of 1.5 ml/min. Detection was carried out using DAD Detector, G 1315D. A linear response (r > 0.99) was observed in the range of 11.14 - 114 μg/ml. The method showed good recoveries (average 101.40 ± 0.14%) and relative standard deviation for intra and inter-day were ≤ 1.5 %. The method was validated for specificity and robustness also.

Keywords: RP-HPLC, Stability indicating, Validation, Ilaprazole.