目的 建立核磁共振法測定13-順阿維A。方法 采用1H-NMR測定13-順阿維A，通過樣品與內(nèi)標物質(zhì)響應(yīng)峰面積比較計算樣品的質(zhì)量分數(shù)以及其中殘留溶劑。結(jié)果 以δ5.64處定量峰和δ8.45處內(nèi)標峰面積比值與13-順阿維A和1,4-對硝基苯質(zhì)量比進行線性回歸，線性關(guān)系良好。13-順阿維A的質(zhì)量分數(shù)為98.5%，RSD值為1.5%（n=3），重復(fù)性良好，與質(zhì)量平衡法測定結(jié)果一致；樣品中殘留溶劑為四氫呋喃，其質(zhì)量分數(shù)為1.0%。結(jié)論 核磁共振法測定13-順阿維A快速、準確、方便，結(jié)果可靠，可以用來進行標準物質(zhì)的測定。

Objective To establish a nuclear magnetic resonance (NMR) method to determine the content of 13-cis acitretin. Methods 1H-NMR was used to characterize 13-cis acitretin. The mass fraction and residue solvent of 13-cis acitretin were calculated by comparing the peak area of 13-cis acitretin with the internal reference substance. Results There was a good regression between quantitative peaks ration of 13-cis acitretin and internal reference substance versus mass ratio of δ5.64 and 8.45. Based on NMR, the mass fraction of 13-cis acitretin was 98.5% with RSD of 1.5% (n = 3) and the residual solvent was tetrahydrofuran with its mass fraction of 1.0%. Conclusion It is a rapid, convenient, and precise method for the determination of 13-cis acitretin by NMR, and the results can be used in reference substance assay experiment.

國家重大新藥創(chuàng)制專項（2011ZX09303-001）；國家質(zhì)量監(jiān)督檢驗檢疫總局公益性行業(yè)科研專項（2012104008-1-14）