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UV and Three Derivative Spectrophotometric Methods for Determination of Ezetimibe in Tablet Formulation
Metreyi Sharma1, Deepali V Mhaske, M Mahadik
1Department of Quality Assurance, Bharati Vidyapeeth University Poona College of Pharmacy, Erandwane, Pune-411 038, India.
Indian Journal of Pharmaceutical Sciences
|January 5, 2010
Summary
New spectrophotometric methods accurately determine ezetimibe in pharmaceuticals. These validated UV and derivative spectrophotometry techniques offer reliable quantification for drug analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Ezetimibe is a cholesterol absorption inhibitor.
- Accurate quantification of ezetimibe in pharmaceutical formulations is crucial for quality control.
Purpose of the Study:
- To develop and validate UV and derivative spectrophotometric methods for ezetimibe determination.
- To assess the linearity and reliability of the proposed analytical methods.
Main Methods:
- Development of UV spectrophotometry at 233 nm (linearity 6-16 µg/ml).
- Development of first, second, and third derivative spectrophotometry at 259.5 nm, 269 nm, and 248 nm, respectively (linearity 4-16 µg/ml).
- Preparation of standard and sample solutions in methanol and validation of all methods.
Main Results:
- Linearity was established for all methods within their respective ranges.
- Calibration graphs demonstrated linearity for UV and derivative spectrophotometric methods.
- All developed methods were extensively validated and showed comparable performance.
Conclusions:
- The developed UV and derivative spectrophotometric methods are suitable for the quantitative analysis of ezetimibe in pharmaceutical formulations.
- These methods provide a reliable and efficient means for pharmaceutical quality control.
- No significant performance differences were observed between the proposed spectrophotometric techniques.
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