Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ANALYSIS OF FEXOFENADINE HYDROCHLORIDE AS A BULK DRUG AND IN TABLET DOSAGE FORM

Pallavi M. Sutar, Deepali A. Bansode and Suneela S. Dhaneshwar*

Abstract

The objective of present work was to develop a validated simple, precise, accurate and specific high performance thin layer chromatographic method for estimation of fexofenadine hydrochloride as a bulk drug and in tablet dosage form. The stationary phase used was precoated silica gel aluminium plates 60 F254 with 250 μm thickness. The mobile phase used for separation was toluene: ethyl acetate: methanol: ammonia (30%) (0.5: 7: 3: 0.6; v/v/v/v). The densitometric quantification was carried out at 220 nm. The calibration curve was found to be linear between 1-10 μg/spot. The method was validated in terms of linearity, precision, repeatability, accuracy, LOD, LOQ, robustness and specificity. The proposed method can be successfully applied for routine analysis of fexofenadine hydrochloride in bulk and tablet dosage form.

Keywords: Fexofenadine hydrochloride, HPTLC, Method development, Densitometric determination, Method validation.