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Validated high performance thin layer chromatographic determination and content uniformity test for rosiglitazone in
S G Walode1, H K Chaudhari, M S Saraswat
1Sinhgad Institute of Pharmaceutical Sciences, Kusgaon (BK), Lonavala, Pune-410 401, India.
Indian Journal of Pharmaceutical Sciences
|September 15, 2010
Summary
A new, efficient high-performance thin-layer chromatography method accurately determines rosiglitazone in tablets. This validated technique offers a fast, cost-effective quality control tool for pharmaceutical analysis.
Area of Science:
- Pharmaceutical Analysis
- Chromatographic Techniques
Background:
- Rosiglitazone is a widely used antidiabetic medication.
- Accurate quantification of rosiglitazone in tablet formulations is crucial for quality control.
Purpose of the Study:
- To develop and validate a simple, rapid, and economical high-performance thin-layer chromatographic (HPTLC) method for rosiglitazone determination.
- To assess the method's suitability for routine quality control analysis of rosiglitazone tablet dosage forms.
Main Methods:
- High-performance thin-layer chromatography (HPTLC) on silica gel 60 GF(254) plates.
- Mobile phase: methanol:toluene:chloroform:triethylamine (1:8:0.5:0.5 v/v/v/v).
- Detection at 264 nm with caffeine as an internal standard.
Main Results:
- The method demonstrated good linearity (1.0-7.0 µg/µl) and accuracy (99.83-100.21% drug recovery).
- Validated parameters include accuracy, precision, specificity, linearity, and ruggedness.
- R(f) values: 0.31 for rosiglitazone and 0.52 for caffeine.
Conclusions:
- The developed HPTLC method is simple, rapid, precise, and economical for rosiglitazone quantification.
- It serves as an effective quality control tool for routine analysis of rosiglitazone in tablet formulations.
- The method meets USP specifications for content uniformity testing.
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