Long-Term Stability of Alkaloids in Solid Dosage Forms

Abstract

There are only few studies showing that shelf-lives of pharmaceutical preparations are often longer than expiration dates (which usually range from 3 to 5 years). The objective of the study was to determine the content of nine solid dosage forms of pharmaceutical preparations with the alkaloid content ranging in age from 23 to 73 years by means of HPLC-MS/MS. Codeine, ethylmorphine, hydromorphone, aminophylline, theobromine, and papaverine were the active pharmaceutical ingredients of the analyzed preparations. The conditions for analysis on the reverse phase C18 of the preparations under study were modified according to literature and optimized. The compounds were identified by ESI+ tandem mass spectrometry. The quantification of the active pharmaceutical ingredient in a particular preparation was based on calibration dependence. There was no evidence of any alkaloid degradation in the pharmaceutical preparations analyzed, and the found content ranged from 93 to 113 % of that declared (with the exception of the papaverine preparation, where the found content of 53.8 % is interpretable by a manufacturing error).