Quantitation of Testosterone,Cypionate-in-Oil Injection Using High-Performance Liquid Chromatography.

A high-performance liquid chromatography assay method for the quantitation of testosterone-cypionate-in-oil injection has been developed. The assay method is very simple, accurate and precise, with a percent relative standard deviation of 1.2 based on five readings. The extraction procedure is very simple compared with a very tedious and time-consuming procedure given in the United States Pharmacopoeia/National Formulary. The USP-NF assay method is based on gas chromatography. The benzyl alcohol (preservative) did not interfere with the assay preocedure. The newly developed method could not be applied to the quantitation of testosterone enanthate since the results were consistently low (-87%). The average recovery of testosterone cypionate from a commercial dosage form was 98.7%.