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目的采用HPLC法测定复方氟米松软膏中4-羟基苯甲酸、4-羟基间苯二甲酸、苯酚及其他有关物质的含量。方法采用Apollo C18色谱柱,流动相A为甲醇-水-冰乙酸(60∶40∶1),流动相B为甲醇-水-冰乙酸(80∶20∶1),梯度洗脱,检测波长270 nm。结果主峰与有关物质能完全分离,4-羟基苯甲酸、4-羟基间苯二甲酸、苯酚的线性范围分别为1.5~9.7、0.7~4.8、0.3~2.7μg·m L~(-1),r分别为0.9999、0.9991、0.9992;平均回收率分别为91.0%、100.5%、86.9%,RSD分别为1.33%、1.09%、0.69%(n=9);检测限分别为1.0、2.0μg·m L~(-1)、4.5 ng·m L~(-1)。结论所用法专属性强、结果准确,可用于复方氟米松软膏中有关物质的检查。
Objective To determine the content of 4-hydroxybenzoic acid, 4-hydroxyisophthalic acid, phenol and other related substances in compound flumetasone ointment by HPLC. Methods Apollo C18 column was used. The mobile phase A was methanol - water - glacial acetic acid (60:40:1), the mobile phase B was methanol - water - glacial acetic acid (80:20:1) nm. The results showed that the main peak was completely separated from the related substances. The linear ranges of 4-hydroxybenzoic acid, 4-hydroxyisophthalic acid and phenol were 1.5 ~ 9.7, 0.7 ~ 4.8 and 0.3 ~ 2.7μg · m L -1, The average recovery was 91.0%, 100.5% and 86.9%, respectively, with RSDs of 1.33%, 1.09% and 0.69%, respectively (n = 9) .The detection limits were 1.0 and 2.0 μg · m L -1, 4.5 ng · m L -1. Conclusions The method used is specific and accurate and can be used for the examination of related substances in compound flumetasone ointment.