QUALITATIVE AND QUANTITATIVE-DETERMINATION OF 2 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 qualita tive and quantitative determination of amonafide (CAS 69408-81-7) and mitonafide (CAS 54824-17-8), two new antineoplastic molecules, in fini shed pharmaceutical dosage forms (tablets) is developed and validated The results submitted in this work suggest that HPLC method is linear (range 0.54 mu g to 2.70 mu g for amonafide, and 1.40 mu g to 5.25 mu g for mitonafide), sensitive (discriminater capacity 0.1098 mu g for a monafide and 0.1324 mu g for mitonafide), precise (coefficient of vari ation less than or equal to 2.39% within run, less than or equal to 1. 18% between run for tablets with amonafide, and less than or equal to 1.38% within run and less than or equal to 0.96% between run for table ts 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 minonafide) 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 th e method, because drug extraction can be influenced by the nature of t he excipients.