High-performance liquid chromatographic determination of vincristine sulfate in preformulation studies

A fast and simple procedure was developed for the quantitative determination of vincristine sulfate for use in preformulation studies. The procedure involves the use of high-performance liquid chromatography with a reverse-phase column and a mobile phase containing the sodium salt of 1-pentanesulfonic acid for ion-pairing. The procedure has been shown to be specific for vincristine sulfate in the presence of forced degradation products of this substance, vinblastine (a structurally similar Vinca alkaloid), and several possible formula excipients. The procedure is linear from 10-200% of the normal injection concentration, and has an assay precision (relative 2 sigma) of +/- 1.6%. Recovery of known samples averaged 99.7%.