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A stability indicating LC method for rivastigmine hydrogen tartrate
B Mallikarjuna Rao1, M K Srinivasu, K Praveen Kumar
1Analytical Research, Custom Chemical Services, Dr. Reddy's Laboratories, Hyderabad 500049, India.
Journal of Pharmaceutical and Biomedical Analysis
|January 25, 2005
Summary
A new reversed-phase liquid chromatographic method accurately quantifies Rivastigmine hydrogen tartrate and its impurities in bulk drugs and formulations. This stability-indicating method is crucial for quality control of the cholinesterase inhibitor.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Chromatography
Background:
- Rivastigmine hydrogen tartrate is a vital cholinesterase inhibitor used in treating cognitive disorders.
- Accurate quantitative determination and impurity profiling are essential for ensuring the safety and efficacy of pharmaceutical products.
- Existing analytical methods may lack the specificity or sensitivity required for comprehensive quality control.
Purpose of the Study:
- To develop and validate an isocratic, reversed-phase liquid chromatographic (RPLC) method for the quantitative determination of Rivastigmine hydrogen tartrate.
- To establish a method applicable for related substance determination in bulk drugs.
- To assess the method's stability-indicating capabilities through forced degradation studies.
Main Methods:
- Utilized an isocratic RPLC system with a Waters X Terra RP18 column.
- Employed an aqueous mobile phase containing sodium-1-heptane sulphonate and acetonitrile.
- Conducted forced degradation studies under acidic, basic, oxidative, thermal, and photolytic stress conditions.
Main Results:
- Achieved excellent chromatographic resolution (>4) between Rivastigmine and its key impurity, (S)-3-(1-dimethylaminoethyl) phenol (Imp 1).
- The method demonstrated specificity, with Imp 1 identified as the primary degradation product under basic hydrolysis.
- High percentage recoveries (95.2-104.3% for Imp 1, 98.6-101.5% for Rivastigmine) confirmed method accuracy and precision across bulk and formulation samples.
Conclusions:
- The developed RPLC method is suitable for the accurate and precise quantitative determination of Rivastigmine hydrogen tartrate and its related substances.
- The method is stability-indicating, effectively distinguishing the active ingredient from its degradation products.
- This validated analytical technique supports robust quality control for Rivastigmine hydrogen tartrate in pharmaceutical manufacturing.