A STABILITY-INDICATING UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF AMOROLFINE HYDROCHLORIDE

摘要

A stability-indicating method by UV spectrophotometry has been developed for the specific determination of Amorolfine HCl in bulk in the presence of its degraded products. The method is simple, accurate, precise, and robust. Experiments were designed for determining linearity, the limit of detection and quantitation, accuracy, precision, and specificity of this analytical method as per the International Organization for Standardization guidelines. The drug substance was exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed using the proposed method to demonstrate the specificity of the method. The proposed method was found to be linear in the concentration ranges from 2-20μg/ml with the linear correlation coefficient of R2= 0.990, and the mean recovery was 95.59 % at a detection wavelength of 215 nm. Although the degradation products of stressed conditions had not been identified, the method had been able to detect the changes due to stress conditions. The stated method can be used as a stability-indicating method with a high degree of linearity, accuracy, and precision for assay of Amorolfine hydrochloride in the routine pharmaceutical analysis of Amorolfine hydrochloride in bulk. The Limit of Detection (LOD) and Limit of Quantification (LOQ) values were found to be 0.052μg/ml and 0.157μg/ml, respectively.