Ion chromatography as an alternative for simultaneous determination of citrate and phosphate in anticoagulant solutions of blood bags

Blood bags are risk III highly complex products designed to collect, store and transfer blood in an efficient and safe way. The national reference for the analysis of this product is the National Institute for Quality Control in Health (INCQS / FIOCRUZ), responsible for the analysis prior to-registration and control of these products. The objective of this study was to perform the optimization and validation of the analytical method for the simultaneous determination of total citrate and sodium acid phosphate monohydrate in anticoagulant solutions of blood bags by ionic comatography. For the optimization of the analytical methodology, the parameters of the proposed method were evaluated and the validation was carried out. The results showed variations of specific analytical conditions related to the mobile phase, temperature and analytical curve. Despite the different detection system, the comparison indicated similarity in the principle of analytical separation of the analytes. The results (selectivity / specificity, linearity, limit of detection, limit of quantification, precision and accuracy) indicated that the new method is reproducible. The study allowed to compare the analytical conditions and to present the relevant aspects of the implementation of the alternative method, mainly, for allowing the simultaneous determination of the analytes of interest. Additionally, it suggests new advances in the quality control of this product and reiterates INCQS participation in sanitary regulatory aspects, using reliable and reproducible analytical methodology under the analytical validation rules of the current legislation.