Development of validated stability indicating RP-UPLC method for the determination of amitriptyline hydrochloride in bulk and its pharmaceutical formulations

摘要

Stability indicating RP-UPLC method was developed for the determination of amitriptyline hydrochloride in bulk and formulations. Chromatographic separation was achieved on a Waters Acquity UPLC system controlled with Empower-2 software. About 5ul of the standard solution was injected into Symmetry C18 (2.1 mmx 100 mmx 1.7 urn; BEH) column, the component was separated with a mobile phase of potassium dihydrogen phosphate buffer (pH 3.0±0.05) and acetonitrile in the ratio 35:65 at aflowrate of 0.30ml/ min and detected at a wavelength of 239 nm. System suitable parameters such as number of theoretical plates and tailing factor were found to be 12434 and 1.2 respectively. The percent of relative standard deviation in the study of intraday precision and inter day precision were found to be 0.136 and 0.336 respectively. Accuracy of the proposed method was found to be within the limits. Linearity limits, slope, intercept and correlation coefficient were found to be 2.5-20.0,55605,3956.2 and 0.9998 respectively. The developed method was found to be robust and rugged. Study of forced degradation indicates that, the percent of degradation was ranged from 8.64% to 18.67% under different degradation conditions. The proposed method can be applied in routine quality control analysis.