Developing a Method to Test Rebamipide Stability
Author Information
Author(s): Sonawane Sandeep, Gide Paraag
Primary Institution: MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Nashik, Maharashtra State, India
Hypothesis
Can microwave energy expedite the forced degradation of rebamipide during stability testing?
Conclusion
A stability-indicating LC method for rebamipide was successfully developed and validated, showing that microwave energy can expedite forced degradation under alkaline conditions.
Supporting Evidence
- The method showed good accuracy and precision with a linear response in the range of 0.5 to 5 μg mL−1.
- Microwave energy was proven to expedite hydrolysis of rebamipide compared to conventional methods.
- The study validated the method according to ICH guidelines, ensuring its reliability for routine analysis.
Takeaway
The researchers created a new way to test a medicine called rebamipide to see how it breaks down over time, and they found that using microwaves makes the process faster.
Methodology
The study used a stability-indicating RP-HPLC assay method validated for specificity, linearity, accuracy, precision, and robustness, with forced degradation studies conducted using microwave energy.
Limitations
The study primarily focused on alkaline hydrolysis and may not fully represent other degradation pathways.
Statistical Information
P-Value
p<0.05
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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