论文部分内容阅读
目的建立HPLC法测定复方丙酸氯倍他索软膏中丙酸氯倍他索和维A酸的含量。方法应用HPLC法,以2种主要成分为指标,采用Wonda Sil C_(18)(250 mm×4.6 mm,5μm)色谱柱;流动相为甲醇-0.1%磷酸溶液(梯度洗脱,采用不同的检测波长);流速为1.0 ml·min~(-1)。结果丙酸氯倍他索和维A酸的线性范围分别为0.06~0.60μg(r=1)和0.03~0.30μg(r=1)。平均回收率分别为99.67%、100.01%;RSD分别为0.66%、1.26%。结论本方法结果准确,精密度高,可同时测定丙酸氯倍他索软膏中丙酸氯倍他索和维A酸的含量,可用于此软膏制剂的质量控制。
OBJECTIVE To establish an HPLC method for the determination of clobetasol propionate and tretinoin in compound clobetasol propionate ointment. Methods The HPLC method was used to determine the contents of the two main components in Wonda Sil C_ (18) (250 mm × 4.6 mm, 5 μm) column. The mobile phase consisted of methanol-0.1% phosphoric acid solution (gradient elution, Wavelength); flow rate of 1.0 ml · min ~ (-1). Results The linear ranges of clobetasol propionate and tretinoin were 0.06 ~ 0.60μg (r = 1) and 0.03 ~ 0.30μg (r = 1), respectively. The average recoveries were 99.67% and 100.01%, respectively. The RSDs were 0.66% and 1.26% respectively. Conclusion The method is accurate and accurate. The method can simultaneously determine the content of clobetasol propionate and tretinoin in clobetasol propionate ointment and can be used for the quality control of ointment preparation.