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Stability indicating HPTLC determination of piroxicam
1Department of Chemical Technology (Autonomous), University of Bombay, Matunga, Mumbai, India.
Journal of Pharmaceutical and Biomedical Analysis
|April 18, 2000
Summary
A new HPTLC method accurately quantifies Piroxicam (PM) and separates it from its precursor, 2-aminopyridine (2AP). This validated, stability-indicating method is suitable for routine pharmaceutical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Piroxicam (PM) analysis requires methods that can separate it from synthesis precursors like 2-aminopyridine (2AP).
- Ensuring the accuracy and precision of analytical methods is crucial for pharmaceutical quality control.
Purpose of the Study:
- To develop and validate a rapid, sensitive, and stability-indicating HPTLC method for Piroxicam (PM) estimation.
- To ensure effective separation of Piroxicam (PM) from its degradation product, 2-aminopyridine (2AP).
Main Methods:
- High-Performance Thin-Layer Chromatography (HPTLC) with spectrodensitometric detection at 360 nm.
- Validation included recovery studies at three concentration levels to assess accuracy and precision.
- TLC aluminium plates precoated with silica gel 60F-254 were used as the stationary phase.
Main Results:
- The optimized solvent system (toluene-acetic acid, 8:2 v/v) provided well-separated spots for Piroxicam (Rf 0.58 ± 0.01) and 2-aminopyridine (Rf 0.23 ± 0.01).
- A linear relationship (r = 0.9982) was observed over a concentration range of 400-800 ng.
- Statistical analysis confirmed the method's accuracy and reproducibility.
Conclusions:
- The developed HPTLC method is rapid, sensitive, accurate, and reproducible for Piroxicam (PM) estimation.
- The method is stability-indicating and economical, making it suitable for routine analysis of bulk drugs and pharmaceutical formulations.