Graham R E, Biehl E R, Kenner C T
J Pharm Sci. 1978 Jun;67(6):792-5. doi: 10.1002/jps.2600670616.
A rapid quantitative analysis of nine selected corticosteroids and corticosteroid esters at room temperature is described. The procedure is similar to the official blue tetrazolium reaction for corticosteroids, except that methylene chloride instead of alcohol USP is used as a solvent and the reagents are dissolved in or diluted with nonaqueous solvents. These two modifications reduce the medium polarity, which increases the reaction rate. The reactions are complete in 7-18 min, and the formazans are stable for at least 90 min. The results from 15 different pharmaceutical formulations, 12 containing hydrocortisone and three containing prednisolone acetate, show that the proposed method gives results that compare favorably with those obtained by the official blue tetrazolium, isoniazid, and phenylhydrazine procedures.
本文描述了在室温下对九种选定的皮质类固醇和皮质类固醇酯进行快速定量分析的方法。该方法与皮质类固醇的法定蓝色四氮唑反应相似,不同之处在于使用二氯甲烷而非美国药典规定的乙醇作为溶剂,且试剂用非水溶剂溶解或稀释。这两个改进降低了介质极性,从而提高了反应速率。反应在7 - 18分钟内完成,生成的甲臜至少90分钟内稳定。对15种不同药物制剂(其中12种含氢化可的松,3种含醋酸泼尼松龙)的分析结果表明,该方法所得结果与法定蓝色四氮唑法、异烟肼法和苯肼法相比具有优势。