Specophotometric method for determination of bismuth oxide in the pharmaceutical products was developed and evaluated. At the “Eczacýbaţý” Pharmaceutical Co., a routine chemical analysis, according to the Italian “Gerolimatos” Pharmaceutical Co procedures, is applied for the determination of bismuth in raw materials and drug products. This method is time consuming and relatively large amount of reagents are used to perform it. Instead, a more rapid, sensitive, selective and convenient procedure was developed to be used as a quality control procedure for the determination of Bi2O3 in mentioned products. Many analytical procedures describe the determination of Bi in the pharmaceutical products. Also there are many reagents available for direct spectrophotochemical determination of Bi. We investigated number of analytical procedures in order to ensure one that would be suitable for application as a quality control procedure. Iodide method in acid medium (0.2-2M H2SO4) was choosen as applicable and acceptable method for the analysis of Bi in mentioned pharmaceutical samples. Validation of the method is done according to the “European Agency for the Evaluation of Medical Products”. Evaluation of the procedure showed that method is reliable, and more accurate and more convenient than the complexometric method. From the data obtained it was seen that amount of reagents used for performing analysis is 8 times lower, amount of sample used for analysis 12 times, and labor is 1.3 times lower than in titrimetric analysis. The Iodide method is much more advantageous than the standard method in determination of Bi in pharmaceutical products.
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