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Method development for analysis of gliclazide in human plasma by using high-performance liquid chromatography
Roohi Obaid1, Tasneem Ahmed, Obaid Ali
1Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, University of Karachi, Pakistan.
Pakistan Journal of Pharmaceutical Sciences
|January 18, 2006
Summary
Dissolution testing is crucial for tablet and capsule bioavailability and quality control. High-performance liquid chromatography (HPLC) offers enhanced sensitivity, precision, and specificity for drug release analysis.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Dissolution requirements have been integral to tablet and capsule monographs since 1970.
- Dissolution testing is recognized for its significant value in ensuring bioavailability and quality control.
- Equivalence in dissolution behavior is pursued considering both bioavailability and quality assurance.
Purpose of the Study:
- To highlight the importance of dissolution testing in pharmaceutical quality control.
- To explore the advantages of high-performance liquid chromatography (HPLC) in dissolution analysis.
Main Methods:
- Review of dissolution testing principles and applications in pharmaceutical quality assurance.
- Discussion of the comparative benefits of HPLC over traditional dissolution profile analysis.
Main Results:
- Dissolution profiles are widely used by the industry to assess drug release rates from formulations.
- HPLC methods demonstrate superior sensitivity, precision, and specificity in dissolution testing.
Conclusions:
- Dissolution testing remains a cornerstone for evaluating drug product performance.
- HPLC presents a valuable analytical tool for enhancing the precision and reliability of dissolution studies.