Kolinski R E, Myrick J W, Bunch E A
J Pharm Sci. 1980 Aug;69(8):951-4. doi: 10.1002/jps.2600690823.
A semiautomated fluorometric method for the analysis of enteric-coated and plain coated diethylstilbestrol tablets is presented. To eliminate interferences from tablet excipients, diethylstilbestrol is extracted into an organic solvent and then into a basic aqueous solution. After UV irradiation, a product of diethylstilbestsrol is formed from which a fluorophore is produced chemically. The fluorescence is measured at an excitation wavelength of 335 nm and an emission wavelength of 410 nm. The coefficient of variation measured for the semiautomated procedure was 0.59%. Assay results agreed well with the USP procedure for tablets containing greater than 1 mg of diethylstilbestrol. Tablet dyes and excipients interfered in the USP procedure, which yielded low results for tablets containing less than 1 mg of diethylstilbestrol. Standard recovery data and assays of tablet composites showed that dyes and other excipients do not interfere with semiautomated procedure.
本文介绍了一种用于分析肠溶包衣和普通包衣己烯雌酚片的半自动荧光法。为消除片剂辅料的干扰，将己烯雌酚萃取到有机溶剂中，然后再萃取到碱性水溶液中。紫外线照射后，形成己烯雌酚的一种产物，通过化学方法从中产生一种荧光团。在激发波长335nm和发射波长410nm处测量荧光。半自动方法测得的变异系数为0.59%。对于含己烯雌酚大于1mg的片剂，含量测定结果与美国药典方法吻合良好。片剂染料和辅料对美国药典方法有干扰，对于含己烯雌酚小于1mg的片剂，该方法结果偏低。标准回收率数据和片剂组合物的含量测定表明，染料和其他辅料不干扰半自动方法。
