Qualitative and quantitative determination of two new antitumor agents from 1-8 naphthalimides in tablets. Validation of a high performance liquid chromatography method.

A high performance liquid chromatography (HPLC) method for the qualitative and quantitative determination of amonafide (CAS 69408-81-7) and mitonafide (CAS 54824-17-8), two new antineoplastic molecules, in finished pharmaceutical dosage forms (tablets) is developed and validated. The results submitted in this work suggest that HPLC method is linear (range 0.54 microgram to 2.70 micrograms for amonafide, and 1.40 micrograms to 5.25 micrograms for mitonafide), sensitive (discriminator capacity 0.1098 microgram for amonafide and 0.1324 microgram for mitonafide), precise (coefficient of variation < or = 2.39% within run, < or = 1.18% between run for tablets with amonafide, and < or = 1.38% within run and < or = 0.96% between run for tablets with mitonafide), accurate (mean recovery 97.55, 98.85, 98.905% for the three different kinds of tablets with amonafide, and 100.73, 101.54% for the two types of tablets with mitonafide) and selective, even when degradation products are present. The volume of extractor liquid must be specially taken into account with regard to the accuracy of the method, because drug extraction can be influenced by the nature of the excipients.