Liquid Chromatographic Determination of Hydrocortisone in Bulk Drug Substance and Tablets: Collaborative Study
- 1 March 1984
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of AOAC INTERNATIONAL
- Vol. 67 (2) , 218-221
- https://doi.org/10.1093/jaoac/67.2.218
Abstract
A normal phase liquid chromatographic (LC) method for determining the hydrocortisone content of bulk drug substance, tablet composites, and individual tablets was subjected to a collaborative study by 6 laboratories. The results showed a mean recovery of 98.5% for an authentic tablet formulation and reproducibility coefficients of variation of 0.97, 1.6, and 2.7% for bulk drug substance, tablet composites, and individual tablets, respectively. Infrared (IR) and thin layer chromatographic (TLC) identification tests, also included in the collaborative study, were satisfactory. The LC method for determining hydrocortisone in bulk drug substance, tablet composites, and individual tablets, with IR and TLC identification, has been adopted official first action.This publication has 1 reference indexed in Scilit:
- High-Performance Liquid Chromatographic Analysis of Hydrocortisone Drug Substance, Tablets, and EnemaJournal of Pharmaceutical Sciences, 1982