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Extractive spectroscopic insulin determination in pharmaceutical formulations
M A Raggi1, L Nobile, F Bugamelli
1Dipartimento di Scienze Farmaceutiche, Università di Bologna, Italy.
Farmaco (Societa Chimica Italiana : 1989)
|August 1, 1997
Summary
Two new methods, spectrophotometric and spectrofluorimetric, accurately determine insulin in pharmaceuticals. These simple and sensitive techniques utilize diethyl ether extraction to remove interfering excipients before analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of insulin is crucial for pharmaceutical quality control.
- Existing methods may face challenges with excipient interference in complex formulations.
Purpose of the Study:
- To develop and validate simple, sensitive, and accurate analytical methods for insulin determination.
- To address excipient interference in pharmaceutical formulations of insulin.
Main Methods:
- Development of a spectrophotometric method (λ = 276 nm).
- Development of a spectrofluorimetric method (λem = 306 nm, λexc = 277 nm).
- Both methods incorporate a diethyl ether extraction step to eliminate excipient interference.
Main Results:
- The proposed spectrophotometric and spectrofluorimetric methods demonstrated high sensitivity and accuracy.
- The extractive step effectively removed excipient interference, allowing for direct spectrometric analysis.
- The methods were found suitable for routine quality control of insulin in pharmaceutical products.
Conclusions:
- Simple, sensitive, and accurate spectrophotometric and spectrofluorimetric methods for insulin determination in pharmaceutical formulations have been successfully developed.
- These methods offer a reliable approach for quality control, effectively managing excipient interference.