Download in electronic PDF format for $75

Abstract:  An assay method based on high-performance liquid chromatography (HPLC), for the quantitation of testosterone in an aqueous suspension, has been developed. The method is very simple compared with a tedious and time-consuming method recommended by the USP-NF. It is an accurate and precise method; the percent relative standard deviation based on five injections was 1.15. The average recovery from four batches of suspension was 100% (percent relative standard deviation, 1.3). A number of inactive ingredients present in the suspension vehicle did not interfere with the assay procedure. Testosterone appears to be a very stable drug since it did not decompose significantly, even on heating. A 15-cm column gave sharper peaks vs. a 25-cm column and the sensitivity of the assay method increased by 400%.

Related Categories: HRT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES

Printer-Friendly Version