High Pressure Liquid Chromatographic Assay for Prednisone in Bulk Drug Substances and Tablets

Autor: Robert E. Graham, Margarito J Uribe, Edward R. Biehl
Rok vydání: 1983
Předmět:
Zdroj: Journal of AOAC INTERNATIONAL. 66:264-272
ISSN: 0004-5756
DOI: 10.1093/jaoac/66.2.264
Popis: A high pressure liquid chromatographic (HPLC) method was developed for the assay of prednisone in bulk drug substances and tablets. The sample was dissolved in water-methanol and an aliquot was analyzed by using HPLC. The average recovery of prednisone added to a prednisone tablet composite was 99.5% with a coefficient of variation of 1.07%. Prednisone was determined in 46 tablets (1-50 mg prednisone/tablet) formulated by 22 manufacturers, using the HPLC method and the USP blue tetrazolium assay. The results show that the HPLC method is more specific and faster than the USP method.
Databáze: OpenAIRE