High-performance liquid chromatographic determination of the X-ray imaging contrast agent, iofratol, in plasma and urine

Iofratol is currently under evaluation as a potential X-ray contrast medium for angiography and myelography. An HPLC method for assaying iofratol in rat and human plasma and urine samples is described. The analysis is based on the reversed-phase chromatographic separation of iofratol and the internal standard (iopamidol) from the endogenous components of biological fluids, and detection by UV absorption at 242 nm. The selectivity of the method was satisfactory. The mean absolute recovery was greater than 90%. The precision and accuracy of the analytical methods were in the range 0.8-7.4 and -7.8 to +9.7%, respectively. The detection limits in plasma (0.1 ml) and urine (0.5 ml) were 0.1 and 0.4 microg (iofratol)/ml, respectively. The analyte was stable in the different biological matrices when stored at room temperature (20 degrees C) for at least 1 day, 4 degrees C for 1 month and -20 degrees C for 1 year.