HPLC Analysis of Amifostine

Abstract

A simple, rapid HPLC method was developed for the routine analysis of amifostine during formulation development. Chromatography was performed on a μBondapak C‐18 column using a mobile phase of 5 mM heptanesulphonic acid and 5% acetonitrile in 0.1 M chloroacetic acid (pH 3.0) at a flow rate of 1.2 mL min−1 using electrochemical detection (Hg/Au electrode). Retention times for amifostine and WR‐149846, the internal standard, were 4.1 and 5.8 min, respectively. The limit of detection was 0.5 μg mL−1 amifostine. Intra‐ and interday precision coefficients of variation were 1.2–4.9% and 2.3–4.9%, respectively. A maximum variation in the values of slopes of several standard curves was 3.9%. The analysis time for each sample was less than 6 min. As the number of samples required for analysis during the formulation development process is high, this method should significantly reduce the total analysis time.