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Photochemical stability of nimesulide
Petra Kovaríková1, Milan Mokrý, Jirí Klimes
1Department of Pharmaceutical Chemistry and Drug Control, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 50005, Hradec Kralove, Czech Republic. kovarikova@faf.uni.cz
Journal of Pharmaceutical and Biomedical Analysis
|March 20, 2003
Summary
Photochemical stability of nimesulide was assessed using HPLC and TLC methods. Degradation products, 2-phenoxy-4-nitroaniline and methanesulfonic acid, were identified and quantified, ensuring drug quality.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID).
- Photochemical degradation can impact drug efficacy and safety.
- Monitoring drug stability is crucial for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate analytical methods for assessing the photochemical stability of nimesulide.
- To identify and quantify nimesulide degradation products under light exposure.
Main Methods:
- High-Performance Liquid Chromatography (HPLC) was used to detect 2-phenoxy-4-nitroaniline.
- Thin-Layer Chromatography (TLC) was employed to detect methanesulfonic acid.
- Standard analytical validation techniques were applied to ensure method accuracy and precision.
Main Results:
- Nimesulide sodium salt solution exposed to 254 nm light showed degradation.
- 2-phenoxy-4-nitroaniline was detected by HPLC, and methanesulfonic acid by TLC.
- The developed HPLC method demonstrated linearity and accuracy for nimesulide determination.
Conclusions:
- HPLC and TLC are effective methods for monitoring nimesulide's photochemical stability.
- The study identified key degradation products, aiding in understanding nimesulide's degradation pathways.
- Validated analytical methods are essential for ensuring the quality and safety of nimesulide formulations.