Novel Method Development, Validation and Stability Indicating Assay Method for Rivastigmine Tartarate Capsule by HPLC

Abstract

The aim of this study is to develop and validate a method for the quantitative analysis of Rivastigmine tartarate capsules 1.5mg. An isocratic HPLC method using a reverse phase C-8 column and a mobile phase along with buffer (pH 3.0) was developed, optimized and validated. The analysis was carried out with a flow rate of 1.5 ml/min at 500C and was monitored at λmax - 220nm. Chromatogram of Rivastigmine tartarate was observed at 11min. The complete elution of Rivastigmine tartarate was achieved in 11.29 min at 220nm. This HPLC method showed good linearity, accuracy, selectivity, and other validation parameters. The recovery (accuracy) at all concentration levels was found to be more than 100% within the range of 102%. System suitability was determined by calculating the percent relative deviation (%RSD) for area five replicates injection of 120ppm in HPLC. All the peaks were resolved from the API with significantly different RT. Rivastigmine tartarate was subjected for stability indicating assay method which must be validated invariably calls for a forced degradation conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Rivastigmine tartarate was found to degrade significantly in base degradation condition and little in thermal, thermal humidity, photolytic, acid and oxidative stress degradation conditions.