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Article Title

Evaluation on the analytical methods for tissue plasminogen activator (tPA) in pharmaceutical formulations

Abstract

Tissue plasminogen activator, tPA, is a thrombolytic agent for treatment of the brain or myocardium infarction. Clot lysis assay is a functional determination method of tPA described in the pharmacopeia. However, the accuracy of clot lysis assay is insufficient because the lysis-time is not determined by the end-point detection. Therefore, an alternative analytical method for the post-marketing quality survey of tPA pharmaceutical formulations is needed. This study was aimed to establish a rapid, precise and cost-saving analytical method for tPA routine test. We have compared methods of capillary zone electrophoresis (CZE), size-exclusion high performance liquid chromatography (SE-HPLC), in vitro clot lysis, enzyme-linked immunosorbent assay (ELISA), and chromogenic substrate assay for the evaluation of recombinant tPA drug products. The results showed that S-2288™, as substrate of chromogenic assay for tPA, exhibited a good linear relationship at tPA concentration of 5-50 μg/mL (correlation coefficient: 0.9988). The intraday precision ranged between 0.5% - 4.3%. Results obtained from our comparative study, suggested that the chromogenic substrate assay is among the best for tPA assay. The features of precision, rapidity and inexpensiveness of this method are suitable for a routine test for tPA in pharmaceutical formulations.

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