Development and validation of flame and electro- thermal atomic absorption spectroscopy for the determination of Aluminium in biological products.

Adjuvant is a main component of vaccines in their final bulk formulations which enhances the immune response against co-inoculated antigens. Aluminium adjuvants have demonstrated safety profile for use in human and veterinary vaccines; however, these adjuvants have been associated with severe local reactions such as erythema, subcutaneous nodules and contact hypersensitivity [1]. Therefore, Aluminium content should be well regulated and an accurate determination of Aluminium is necessary in the production of vaccines for quality control purposes. The analytical methods employed for the determination and quantitation of Aluminum includes spectrometric methods based on the reaction of Aluminum with Aluminon or 8-hydroxyquinoline; titrimetric method involving EDTA, and atomic absorption spectroscopy [2-4]. In quality control laboratories estimation of Aluminium in biological products is generally performed using spectrophotometric method which in some cases shows inadequate quality. In the present study a flame atomic absorption spectroscopy (FAAS) technique for quantification of Aluminum in human bacterial (DTP and dT) and foot mouth disease (FMD) vaccines has been developed and validated. In order to liberate Aluminium from sample complex matrix, acid digestion was applied. Influential parameters on digestion such as kind of acids and temperature for different matrixes were optimized. Interference effect of matrix components on the final response has been studied. The developed method was found to be linear in the range of 10-120 mgL-1 with detection limit of 3.33 mgL-1 based on three standard deviation of the blank. The procedure was found to be accurate for different vaccines with recoveries of 92.0 and 98.0% with RSD of less than 5% for two different kinds of vaccines. The current method can be suitably replaced by developed method.