鉴定和表征氯可托龙戊酸酯中的三种杂质。
Identification and characterization of three impurities in clocortolone pivalate.
机构信息
School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, People's Republic of China.
出版信息
J Pharm Biomed Anal. 2012 Mar 25;62:167-71. doi: 10.1016/j.jpba.2011.11.021. Epub 2011 Dec 8.
Clocortolone pivalate is a synthetic corticosteroid that can be used to cure corticosteroid-responsive dermatoses. Three previously unknown impurities detected by HPLC were isolated by semi-preparative LC. Based on the NMR and MS spectral data, these were identified as (6R,9R,16R)-9-chloro-6β-fluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione-21-pivalate (Impurity I), (9R,16R)-9-chloro-4-fluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione-21-pivalate (Impurity II) and (9R,16R)-9-chloro-6α-fluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione-11,21-dipivalate (Impurity III). The possible mechanism of the formation of the impurities is discussed.
倍他米松戊酸酯是一种合成的皮质类固醇，可用于治疗皮质类固醇反应性皮肤病。通过高效液相色谱法检测到三种以前未知的杂质，并通过半制备液相色谱法将其分离。根据核磁共振和质谱谱数据，这些被鉴定为（6R，9R，16R）-9-氯-6β-氟-11β，21-二羟基-16α-甲基孕甾-1,4-二烯-3,20-二酮-21-戊酸酯（杂质 I），（9R，16R）-9-氯-4-氟-11β，21-二羟基-16α-甲基孕甾-1,4-二烯-3,20-二酮-21-戊酸酯（杂质 II）和（9R，16R）-9-氯-6α-氟-11β，21-二羟基-16α-甲基孕甾-1,4-二烯-3,20-二酮-11,21-二戊酸酯（杂质 III）。讨论了杂质形成的可能机制。
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