摘要
建立测定二类新药依索拉定片剂含量的紫外分光光度法。用甲醇作溶剂，在２２１ｎｍ波长处测定１～１５ｍｇ／Ｌ依索拉定模拟样品的吸光度Ａ。结果：Ａ＝０．０３２＋０．０７３ｃ，ｒ＝０．９９９５（ｎ＝５）。方法回收率为９８．６３％（４．０ｍｇ／Ｌ，ｎ＝４）；天内天间的ＲＳＤ为１．２１％（４．０ｍｇ／Ｌ，ｎ＝４）。模拟样品的最低检测浓度为１．０ｍｇ／Ｌ。结论：本法具有准确度高、精密度好、试剂价廉，操作简便及便于推广等优点，可用作为依索拉定开发中有实用价值的分析方法。
PURPOSE To establish an ultraviolet spectrometry for the determination of irsogladine in tablets in the development of irsogladine preparation.METHODS Using methanol as solvent, the absorbance of irsogladine in the spiked sample could be measured at 221 nm by the UV spectrometry.RESULTS A calibration graph was obtained according to the absorbance A and the concentration c.The calibration graphy was linear in the range of 1～15 mg/L of irsogladine.The equation is as follows:A=0.032+0.073 c,r=0.999 5(n=5). In the spiked samples, the recoveries of irsogladine were 98.91%(8.0 mg/L,n=4)and 98.63 %(4.0 mg/L,n=4)respectively. The RSD of within day and day-to-day were 1.21%(4.0 mg/L,n=4)and 2.68%(8.0 mg/L,n=4)respectively; the detection limit was 1.0 mg/L. CONCLUSIONS The results above show that the UV spectrometry established by us have the advantages of high accuracy, good precision, cheap reagents, simple procedure and easy popularization, so it is a method of usable value in the development of irsogladine preparation.
出处
《上海医科大学学报》
CSCD
1996年第4期299-300,共2页
Journal of Fudan University(Medical Science)
