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Validated HPTLC method of analysis for artemether and its formulations
Nitin G Tayade1, Mangal S Nagarsenker
1Department of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai 400098, India.
Journal of Pharmaceutical and Biomedical Analysis
|October 19, 2006
Summary
A new high-performance thin-layer chromatographic (HPTLC) method accurately analyzes artemether in bulk and formulations. This validated technique offers a simple, sensitive, and rapid approach for quality control.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Chromatography
Background:
- Artemether is a crucial antimalarial drug.
- Accurate quantification of artemether in bulk and formulations is essential for therapeutic efficacy and patient safety.
- Existing analytical methods may lack the required sensitivity, precision, or speed for routine quality control.
Purpose of the Study:
- To develop and validate a simple, sensitive, precise, and rapid high-performance thin-layer chromatographic (HPTLC) method for artemether analysis.
- To apply the developed HPTLC method for the quantitative determination of artemether in both bulk drug and various pharmaceutical formulations.
Main Methods:
- High-performance thin-layer chromatography (HPTLC) utilizing TLC aluminum plates precoated with silica gel 60F-254.
- A mobile phase comprising toluene-ethyl acetate-formic acid (8:2:0.3, v/v/v).
- Densitometric detection in reflectance mode at 565 nm, with validation for precision, accuracy, recovery, and robustness.
Main Results:
- The HPTLC method achieved a distinct R(f) value of 0.50 ± 0.03 for artemether, indicating good separation.
- Excellent linearity was observed in the concentration range of 200-1000 ng per spot, with a correlation coefficient (r²) of 0.9904.
- The method demonstrated high sensitivity with limits of detection (LOD) and quantitation (LOQ) at 65.91 and 197.74 ng per spot, respectively.
Conclusions:
- The developed HPTLC method is simple, sensitive, precise, and rapid for artemether quantification.
- The method's robustness and accuracy were confirmed through rigorous validation.
- Successfully applied to analyze artemether in lipid-based parenteral and oral solid dosage formulations, proving its practical utility in pharmaceutical quality control.
