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Stability-indicating Method for the Estimation of Riluzole in Tablets
T Neeha1, P Bhargavi, A Aruna Jyothi
1Department of Pharmaceutical Analysis, K. V. S. R. Siddhartha College of Pharmaceutical Sciences, Pinnamaneni Polyclinic Road, Siddhartha Nagar, Benz Circle, Vijayawada-520 010, India.
Indian Journal of Pharmaceutical Sciences
|October 2, 2013
Summary
A new stability-indicating method accurately measures riluzole in bulk and tablets. This high-pressure liquid chromatography method is validated and effective for quality control of riluzole formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Riluzole is a medication used to treat amyotrophic lateral sclerosis (ALS).
- Ensuring the stability and accurate quantification of riluzole in pharmaceutical formulations is crucial for patient safety and therapeutic efficacy.
Purpose of the Study:
- To develop and validate a stability-indicating analytical method for the estimation of riluzole.
- To assess the degradation behavior of riluzole under various stress conditions.
Main Methods:
- A stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed using a photodiode array (PDA) detector.
- Riluzole samples (bulk and tablet dosage forms) were subjected to stress conditions including light, heat, humidity, acid/base hydrolysis, and oxidation.
- The developed method was validated according to International Conference on Harmonization (ICH) guidelines.
Main Results:
- The method demonstrated good resolution between riluzole and its degradation products.
- Degradation of riluzole was observed under acidic, basic, oxidative, and thermal stress conditions.
- The method showed linearity in the range of 10-50 μg/ml with a correlation coefficient of 0.9998, indicating high precision and accuracy (assay 100.92%, recovery 101.10%).
Conclusions:
- The developed RP-HPLC-PDA method is stability-indicating, specific, and suitable for the quantitative analysis of riluzole in bulk and pharmaceutical formulations.
- The method provides a reliable tool for quality control and stability assessment of riluzole products.
