Kaffenberger R M, Eichhold T H, Doyle M J
Procter & Gamble Company, Miami Valley Laboratories, Cincinnati, OH 45239-8707.
J Chromatogr. 1990 May 4;505(2):349-56. doi: 10.1016/s0021-9673(01)93049-3.
A rugged reversed-phase high-performance liquid chromatographic method suitable for the quantitative determination of tebufelone, a new anti-inflammatory drug, in bulk drug, various pharmaceutical formulations and animal feed admixtures is described. Tebufelone was easily separated from synthetic by-products and detected by ultraviolet absorption (280 nm). Standard curves were linear (r2 greater than 0.999) over 2 orders of magnitude with a detection limit of 0.1 microgram/ml at a signal-to-noise ratio of 2 (0.05 ml injected). Recovery of tebufelone from bulk drug and dosage formulations was greater than 99% with a coefficient of variation of 1.8% throughout the range of the standard curve. Recovery of tebufelone from feed admixtures was 96-102% with a less than 5% relative standard deviation at the levels assayed.
