Quantification of Ioversol in Injection Dosage form Using HPLC: Stability Indicting Method Development and Validation

Abstract

Background: Ioversol (IVL) is a radiographic contrast agent employed in the diagnostic radiography. In this investigation, our aim was to develop and validate a simple and rapid HPLC-DAD method for determination of IVL in bulk and injection dosage form. Methods: IVL separation and analysis was performed on Zodiac phenyl C18 column (250 mm × 4.5 mm; 5 µ particle size) using water-methanol (90:10 by volume) as mobile phase system and with detection at 254 nm. Results: The retention value of IVL was 4.11 min. The method linearity range was found 254.5-763.5 µg/ml with LOQ and LOD values of 2.376 µg/ml and 0.729 µg/ml, respectively. The accuracy (̴ 100%) and precision (< 2.0%) were within the acceptance criteria. Stability indicating ability of the method was proved by stress degradation studies. Adoptability of this method was assessed with application to marketed injection dosage form with good accuracy (recovery 100.49%) and precision (RSD 0.715%). Conclusion: By adopting this method one can analyze IVL in injection dosage form in less than 10 min and hence this method is time saving and enables the estimation of large number of samples.