VALIDATION OF Hib POTENCY TESTING PROCEDURE (TOTAL AND FREE PRP CONTENT) USING ION EXCHANGE CHROMATOGRAPHY METHOD

Abstract

Validation of analytical procedure is one of the important steps to evaluate the suitability and confirm the validity of the method corresponding to the specific conditions of each laboratory in order to ensure the reliability of the testing results. The potency of Hib component in vaccines (total and free PRP content) could be determined by three different methods including: ribose, phosphorus and ion exchange chromatography. This study was conducted to confirm whether the procedure for determining PRP content in Hib-containing vaccines using ion exchange chromatography method is compatible with the actual conditions of the Physicochemical Department’s laboratory. The research uses the experimental descriptive method in the laboratory. Since this procedure has not been described in the Vietnamese Pharmacopoeia so far, it was fully validated with the parameters of accuracy, precision, robustness, specificity and linearity meeting the requirements and with a limit of quantification of 0,066 mg/ml.