A Quick and Simple Polarographic Method for Aluminum Measurement in Recombinant Hepatitis B Vaccine

Background and Objective: Aluminum salts are among the most common useful additive compounds in preparation of human and animal vaccines. Aluminum phosphate and aluminum hydroxide are two additives that show good immunoadjuvant effects with many antigens. Aluminum-containing vaccines lead to a better and longer immune response compared to adjuvant-lacking vaccines. The Chromogenic methods used for determination of aluminum amounts in manufacturing centers are time-consuming and requires some experienced technicians to obtain accurate results. This study aimed to design and validate a simple polarographic method to measure aluminum in recombinant hepatitis B vaccine. Methods: In this study, the effects of temperature, pH, potential range and potential scan rate on the polarographic method of measuring aluminum in hepatitis B vaccine was evaluated and the optimal values for each of these factors were achieved. Results: In order to measure aluminum, temperature of 60 °C and pH of 4.5 were found as the optimal values. Implementation of polarographic method in the potential range of 0.25 to 0.1 volts had a better signal. Conclusion: Since the polarography method is more simple, accurate and faster than the chromogenic methods, it is suitable to be used for the measurement of aluminum in hepatitis B vaccine and it is recommended to be used in quality control laboratories for biological products.