METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES FOR DETERMINATION OF EBASTINE IN TABLET DOSAGE FORM BY USING RP-HPLC

Abstract

RP- HPLC method is developed for estimation of Ebastinein the tablet dosage form. Employing a simple and stability-indicating HPLC method, using stress degradation studies, drug was well separated from the degradantswith good peak resolution.  Mobile phasewas prepared with using ortho phosphoric acid and diethylaminebuffer, methanol and acetonitrile in the ratio of 10: 70: 20 v/v. The chromatographic separation was achieved by using Kromasil 100 C8, 250x4.6mm, 5 µLat a flow rate of 1.0 mL/min. the detection wavelength selected is 210 nm.The drug was subjected for degradation studies acid degradation, base degradation, peroxide degradation, photolytic degradation and thermal degradation. Ebastine was eluted at a retention time of 6 minutes. the developed method is used for assay of orodispersible tablets containing Ebastine. The percentage assay was found to be 99.82 %. Linearity of the drug for the developed method was found within a range of 80 µg/ml to 800 µg/ml. the method was precise with % RSD values below 2. The method is found accurate with % recoveries of 99.3 to 100.6 %. The method was validated as per ICH guidelines. Validation results confirm the applicability of the developed method for quality analysis and stability studies of the regular product on the manufacturing stream.

Keywords: Ebastine; degradation; RP-HPLC; method development; Validation