摘要
目的采用HPLC法对艾地苯醌片的有关物质进行研究。方法建立艾地苯醌片有关物质的液相研究方法,色谱条件为：C18柱（4.6 mm×250 mm,5μm）,以甲醇-水（72：28）为流动相,流速：1.0m L·min^-1,梯度洗脱时间为40 min,检测波长为278 nm,柱温为30℃并对片剂中的有关物质进行了测定。结果艾地苯醌与有关物质分离良好,有关物质的线性范围为2.02-12.12μg·m L^-1,最低检出限为0.68 ng。结论该方法快速简便,准确,可用于制剂中有关物质和含量的测定。
Objective To study the related substances in Idebenone tablets. Methods HPLC method was used. The column was C18（4.6 mm×250 mm, 5 μm）, the mobile phase was methanol-water（72 ：28） at 1.0 m L·min^- 1, and the detective wavelength was 278. Results The related substances in Idebenone was separated well, the linearity was at 2.02- 12.12 μg·m L^- 1, the minimum detection limit is 0.68 ng. Conclusion This method is quick, easy, accurate and can be used for the determination of related substances in Idebenone tablets.
出处
《中南药学》
CAS
2015年第2期189-192,共4页
Central South Pharmacy
