A practice article was recently published in the European Journal of Hospital Pharmacyon the determination of content uniformity of busulfan capsules by liquid chromatography-mass spectrometry.
Oral high dose busulfan (1,4-butanediol dimethanesulfonate) is frequently used in conditioning regimens prior to haematopoietic stem cell transplantation. As tablets with high dose busulfan are not commercially available, it is common practice to extemporaneously prepare capsules in hospital pharmacies.

In the study, described in the Journal, an HPLC–mass spectrometry (MS) method that was previously validated for quantification of plasma levels of busulfan was adapted for determination of the content uniformity of capsules comprising 50 mg of busulfan for high dose regimens.

The results found intraday and interday variability and imprecision were less than 2.2% indicating high specificity and sensitivity of this novel assay.

The full text of the research article is available of the EJHP website here