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dl-15-甲基PGF_(2α)及其甲酯为前列腺素PGF的衍生物。它们的临床剂量甚小,其合成生产工艺及结构特征表明可能有多种异构体存在,且异构体间的生物活性差异很大。建立具有高专属性、灵敏度以及对各种制剂适用的分析方法是改进生产工艺、深入各项研究和临床安全有效使用所面临的迫切课题。本文报道的反相HPLC直接测定法用ODS柱、UVλ197nm检测、甲醇—水—醋酸为流动相,合成杜鹃素为内标,可对dl-15-甲基PGF_(2α)及其甲酯的各种差向和顺反异构体进行分离和分别直接定量。本法分辨率高,最低检测量为0.03μg,操作简便,定量线性关系良好,分析误差小于3%(CV),节省试剂,并可发展成制备工艺。本法适用于15-甲基PGF_(2α)及其甲酯的合成原料和各种制剂的分析。
Dl-15-methyl PGF(2α) and its methyl ester are derivatives of prostaglandin PGF. Their clinical dose is very small. Their synthetic production process and structural characteristics indicate that there may be multiple isomers, and the biological activity among isomers varies greatly. The establishment of analytical methods with high specificity, sensitivity, and suitability for various preparations is an urgent task for improving production processes, in-depth research, and clinical safe and effective use. The reversed-phase HPLC direct determination method reported in this paper was based on ODS column, UV 197 nm detection, and methanol-water-acetic acid mobile phase. Synthetic rhododendron was used as an internal standard, which can be used for each of dl-15-methyl PGF 2 alpha and its methyl esters. The species differentials and cis and trans isomers were separated and directly quantified. The method has high resolution, the minimum detection amount is 0.03 μg, the operation is simple, the quantitative linear relationship is good, the analysis error is less than 3% (CV), the reagent is saved, and the preparation process can be developed. This method is applicable to the analysis of synthetic raw materials and various preparations of 15-methyl PGF_(2α) and its methyl esters.