The determination of methanesulphonic acid content of busulfan drug substance and busulfan (Myleran) tablets by ion chromatography.

A robust ion chromatographic procedure is described for the determination of the methanesulphonic acid content of busulfan drug substance and busulfan (Myleran) 2 mg tablets. The sample was dissolved in aqueous acetonitrile, butanesulphonic acid was added as an internal standard and the solution was injected onto an ion selective column, with ion suppression and conductivity detection. The method has been fully validated and is linear over the concentration range 0.295-14.73 microg of methanesulphonic acid/ml. The method has been demonstrated to be stability indicating.