Development and validation of a stability indicating spectrofluorimetric method for the determination of lanzoprazole via its degradation product

Abstract

A simple and a stability indicating spectrofluorometric method was developed and validated for the analysis of lanzoprazole via its degradation product in formulation. The proposed method was based on measuring the fluorescence intensity of the degradation products at 410 nm for the emission wavelength and at 322 nm for the excitation wavelength. The method was validated in accordance with the ICH requirements, which involved accuracy, precision, linearity, selectivity and both limit of detection and limit of quantification. Linearity was obtained in concentration range 1-10 μg/ml. The mean percentage recoveries were 99.39 ± 0.11%. The degradation product was obtained in acidic stress condition. The proposed procedure was successfully applied for the determination of lanzoprazole in pure form, laboratory-prepared mixtures, tablet and expired batch. Statistical comparison between the results obtained by the suggested method and that obtained by the official method for the determination of the drug was done and it was found that there were no significant differences between them. For ease and convince of such method, where analysis can be done within a short period of time in comparison with the chromatographic methods. The method was validated according to United States Pharmacopeia Guidelines. © 2014 Ghaleb Oriquat et al.