高效液相色谱法测定烯丙孕素微囊中烯丙孕素的含量

Determination of the Content of Altrenogest in Microcapsule by High Performance Liquid Chromatography

关键词:  烯丙孕素  微囊  高效液相色谱法  含量测定

Key words:  altrenogest  microcapsule  HPLC  content determination

摘要:

建立了烯丙孕素微囊中烯丙孕素的高效液相色谱含量测定方法，采用Kromasil 100-5 C18 (250 mm×4.6 mm, 5 μm) 色谱柱,以流动相水-乙腈(30∶70，V/V)、检测波长236 nm、流速1.0 mL/min、柱温30 ℃、进样量20 μL为色谱条件，无水乙醇为溶剂对微囊进行加热超声提取。结果表明，在烯丙孕素保留时间无干扰峰出现，在5~30 μg/mL的浓度范围内线性关系良好，回归方程为A=21468C-10887,R_²=0.9993；总平均回收率为（100.96±1.14）%，RSD为1.13%；三个浓度水平下RSD分别为0.83%、1.16%和1.8%。该方法准确可靠、选择性好、简便、快速，可用于烯丙孕素微囊含量测定及质量评价。

Abstract:

A high performance liquid chromatography method was developed to determine the contents of altrenogest in microcapsule. A Kromasil 100-5C18 (250 mm×4.6 mm, 5 mm) column was used for sample separation, water-acetonitrile (30 :70, v/v) was used as mobile phase, detection wavelength was 236 nm; flow rate was1.0 mL/min; column temperature was 30°C; and injection volume was 20 μL. Altrenogest was ultrasonically extracted from microcapsule by absolute ethanol. The results showed that there was no interference peak at the retention time of altrenogest. The linearity was good in the concentration range of 5-30 μg/mL. The regression equation was A=21468C-10887, R²=0.9993; the average recovery rate was 100.96± 1.14, RSD is 1.13%. In conclusion, the developed method was accurate, reliable, selective, simple, fast, and can be used for the determination and quality evaluation of altronegest microcapsule .