摘要
目的:对二丙酸倍他米松主要水解产物的结构进行鉴定,为其稳定性及制剂处方研究提供参考。方法:对二丙酸倍他米松原料药进行强制降解试验,采用高效液相色谱法对水解产物进行分析、质谱法对水解产物进行结构鉴定,并利用合成所得杂质对照品对降解产物的结构进行确证。结果:二丙酸倍他米松在碱性和酸性条件下均可进行水解反应,且降解杂质不相同。其可水解产生倍他米松17-丙酸酯与倍他米松21-丙酸酯,2种单丙酸酯均可进一步水解成倍他米松。但二丙酸倍他米松在碱性条件下极易水解,降解产物可进一步降解;在酸性条件下水解则需要相对较强的反应条件,降解产物不易进一步水解。结论:二丙酸倍他米松在碱性和酸性条件下的水解杂质不相同,其3个主要的水解产物分别为倍他米松17-丙酸酯、倍他米松21-丙酸酯及倍他米松。
OBJECTIVE： To identify the structure of the hydrolysate of betamethasone dipropionate, and to provide reference for the stability and formulation research. METHODS： Forced degradation test of betamethasone dipropionate was carried out; the hydrolysates were analyzed by HPLC, and the hydrolysates were identified by MS; and the structures of the hydrolysates were confirmed through comparison with synthetic impurities. RESULTS： The betamethasone dipropionate can be hydrolyzed under alkaline and acid conditions, and produced different impurities. The two main hydrolysis products of betamethasone dipropionate were betamethasone 17-monopropionate, betamethasone 21-monopropionate, and can be further hydrolyzed into betamethasone. Betamethasone dipropionate could be easily hydrolyzed under alkaline condition, and the degradation products can be further degraded. Under acid condition, the hydrolysis required relatively stronger reaction, and its degradation products can be degraded hardly. CONCLUSIONS： The hydrolysis impurities of betamethasone dipropionate in alkaline and acid conditions are not the same. Three main hydrolysis products were betamethasone 17-monopropionate, betamethasone 21-monopropionate and betamethasone.
出处
《中国药房》
CAS
CSCD
2014年第33期3137-3140,共4页
China Pharmacy
关键词
二丙酸倍他米松
水解产物
杂质
结构鉴定
Betamethasone dipropionate
Hydrolysate
Impurity
Structure identification
