Novel Method Development, Validation and Stability Indicating Assay Method for Rivastigmine Tartarate Capsule by HPLC Mathur Aditya1,*, Vejendla Ravikumar2 1Assistant Professor, Dept. of Pharmaceutical Chemistry, B.M College of Pharmacy, Gurugram 2Professor, Dept. of Pharmaceutical Analysis, St. Mary Pharmacy College, Hyderabad *Corresponding Author E-mail: mathuradity@gmail.com
Online Published on 03 October, 2023. 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 50°C 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. Top Keywords Rivastigmine tartarate, Exelon®, RP-HPLC- method development, Validation, Stability indicating assay method, Forced degradation. Top |