HPLC Assay And Stability Testing of Adrenaline from Compounded Rectal Suppositories

Abstract

 The adrenaline content of Tonogen (adrenaline)+benzocaine HCl+Peru balsam+oleum ricini+adeps solidus rectal suppository, a commonly prescribed non-official topical compounded preparation for piles (hemorrhoids) in Hungary, manufactured in a community pharmacy by fusion molding, was assayed and its stability during storage at 5-6 °C for 28 days in primary and secondary packaging was determined by a validated HPLC method. The 68 rectal suppositories manufactured showed a variance of 114% to 58% in their actual adrenaline contents compared to the nominal average adrenaline concentration in the bulk mass at time t0 (the latter value was measured in the last suppository). Within the group of suppositories included in the stability study, the lowest measured concentration (suppository Nr. 41; 7.64 μg/g) was 77% of the nominal average bulk concentration at time t1, while the highest measured concentration (suppository Nr. 46; 11.35 μg/g) was 114% of the nominal average bulk concentration at time t0. During the storage period, the adrenaline content of the suppositories did not show any significant decrease. The inhomogeneity of adrenaline contents found among suppositories did not show any significant trend in the function of manufacturing order (if the last suppositories manufactured were excluded).