吲哚美辛胶囊含量测定方法的改进

Indomethacin Capsules HPLC Method

目的:依据《中国药典》2005年版二部测定不同生产厂家的吲哚美辛胶囊含量,测定的含量值偏低且重现性差,分析吲哚美辛理化性质认为原方法从吲哚美辛胶囊内容物中提取吲哚美辛不完全。为此,进行了方法改进。方法:由药典方法"振摇提取"改进为"研磨内容物,超声提取1h";对两种测定方法进行了统计分析,表明方法间存在系统误差;对改进方法进行了方法学考察,结果吲哚美辛进样量在0.20014μg～4.0028μg之间线形关系良好,回归方程为y=1379.1x+3.2886,r=0.9997(n=6)。结论:采用改进方法测定吲哚美辛胶囊含量,具有良好精密度和重现性。

Objective： The purpose of the basis of ＂Chinese Pharmacopoeia＂ 2005 Determination of two different manufacturers indomethacin capsule content, the content determination of the value of the low reproducibility and poor analysis of indomethacin the original method of physical and chemical properties of indocyanine Yoshiyuki from the capsule to extract the contents of indomethacin incomplete. To this end, a way to improve. Methods： Prescribed by USP, ＂Extraction shake＂ improve ＂the contents grinding, ultrasonic extraction lh＂; determination of the two methods of statistical analysis show that the systematic error between methods; methods for improving the methodology study, the results of indole indomethacin injection volume 0. 20014μg-4. 0028μg in a good relationship between the linear regression equation was y = 1379. 1x ＋3. 2886, r = 0. 9997 （n= 6）. Conclusion： The method to improve indomethacin capsule content, with good precision and reproducibility.