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Development of a Quantitative Determination Method for Aluminum Ions in Adsorbed Drugs Using Atomic Absorption
D D Makarishcheva1, O N Kolesnikova1, V E Tregubova1
1Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051 Russia.
A new atomic absorption spectroscopy method accurately quantifies aluminum ions (Al3+) in immunobiological drugs. This validated technique offers a reliable alternative for quality control in pharmaceutical analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Science
- Spectroscopy
Background:
- Aluminum ions (Al3+) are used in some immunobiological drugs.
- Accurate quantification of Al3+ is crucial for drug safety and efficacy.
- Existing methods may have limitations for specific applications.
Purpose of the Study:
- To develop and validate a quantitative determination method for Al3+ in immunobiological drugs.
- To establish the analytical performance of the proposed method.
- To provide an alternative analytical approach for quality control.
Main Methods:
- Atomic absorption spectroscopy with electrothermal atomization (ETAAS) was employed.
- Optimization of aluminum hydroxide gel preparation conditions was performed.
- Method validation included assessment of accuracy and precision.
Main Results:
- The analytical range for Al3+ was determined to be 10-50 µg/L.
- The method demonstrated acceptable accuracy and in-laboratory precision.
- Optimized conditions for aluminum hydroxide gel preparation were identified.
Conclusions:
- The developed ETAAS method is suitable for the quantitative determination of Al3+ in immunobiological drugs.
- This method serves as a viable alternative to existing techniques.
- The validated method supports robust quality control of pharmaceutical products.
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