| 摘要: |
| 建立了烯丙孕素口服液中烯丙孕素含量测定的高效液相色谱分析方法及样品前处理方法。采用正相高效液相色谱法，前处理溶剂为异丙醇-正己烷（5:20），测定方法为：色谱柱为ZORBAX CN C18柱（250 *4.0 mm，5 μm），流动相正己烷-异丙醇（98:2），流速1.0 mL/min，柱温35 ℃，检测波长235 nm。该方法中烯丙孕素的定量限浓度为804.9 ng/mL，线性范围为0.401-0.601 mg/mL，平均回收率为100.3%，该方法前处理简单、准确度高，可适用于该制剂中烯丙孕素的定性定量测定。 |
| 关键词: 烯丙孕素口服液 含量测定 高效液相法 |
| DOI： |
| 投稿时间：2019-12-16修订日期：2020-02-25 |
| 基金项目: |
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| Content Determination of Altrenogest Oral Solution by HPLC |
|
| (Tianjin Speerise Challenge Biotechnology Corporation) |
| Abstract: |
| This research established not only a HPLC method to determine the content of Altrenogest in Altrenogest Oral Solution but also sample treatment method. This research adopted the normal-phase HPLC,using hexane-isopropyl alcohol (5:20) as the extracting solvent.The test condition is like that:separate column is the Agilent ZORBAX CN C18 (250 mm×4.6 mm,5 μm) column,the mobile phase is hexane-isopropyl alcohol(98：2),the flow rate is 1.0 mL／min,the column temperature is 35℃ and the detection wavelength is 235 nm.In this method,the limit of quantitation is 804.9 ng/mL,the linear range of Altrenogest is 0.401-0.601 mg/mL, the average recovery rate is 100.3%.This method is suitable for qualitative and quantitative determination of Altrenogest with simple pretreatment procedure of the sample and high accuracy. |
| Key words: Altrenogest Oral Solution ,content determination,HPLC |
