摘要
目的建立注射用福莫司汀含量测定及有关物质检查的高效液相色谱测定方法。方法采用高效液相色谱法,色谱柱:Zorbax SB-C18(4.6 mm×150 mm,5μm);流动相:甲醇-0.2%磷酸二氢铵(2∶1.5,V/V);流速:1 ml/min;紫外检测波长:230 nm。结果进样量在0.05～10.00μg范围内与色谱峰面积呈良好的线性关系(r=0.9998);福莫司汀平均回收率为99.72%,RSD为0.16%;所检测的有关物质含量约为0.5%。结论该法简便、快速,结果准确、可靠,重复性好,可用于注射用福莫司汀含量测定及有关物质检查。
Objective To establish an high performance liquid chromatography method for the content determination of Fotemustine for injection and related substances. Methods The assay was conducted on a Zorbax SB-C18 column （ 4.6 mm×150 mm,5μm） and the mobile phase was methanol-0.2% ammonium phosphate monobasic（2：1.5 ,V/V）at a flow rate of 1.0 ml/min. The detection wavelength was 230 nm. Results The linear range for Fotemustine was 0. 05- 10.00 lag （r =0. 9998）. The average recovery rate was 99.72% ,and RSD was 0. 16%. The related substances accounted for about 0. 5%. Conclusion This method can be applied to quantitative determination of Fotemustine for injection.
出处
《解放军药学学报》
CAS
2011年第6期535-536,539,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
福莫司汀
有关物质
含量测定
高效液相色谱法
fotemustine
the related substances
content determination
high performance liquid chromatography
