高效液相色谱法测定草酸萘呋胺酯包衣微丸的含量

Content determination of naftidrofuryl oxalate coated pellets by HPLC

目的建立草酸萘呋胺酯包衣微丸的含量测定方法。方法采用高效液相色谱法测定,色谱柱:Hypersil BDS C6H5(5μm,4.6×250mm),柱温25℃,流动相:0.05mol.L-1乙酸钠(用磷酸调节pH4.0)-乙腈(40:60),流速:1.0ml.min-1检测波长:283nm,进样量:20μl。结果草酸萘呋胺酯在10μg.ml-1～100μg.ml-1范围内,其峰面积与浓度成良好的线性关系(r=0.9999);平均回收率为99.75%,RSD=0.79%(n=6)。结论该方法可靠,准确,适用于该制剂的含量测定。

Objective To establish a method for the content determination of naftidrofuryl oxalate coated pellets. Methods HPLC method was used, the analytic column was Hypersil BDS C6H5（5μm, 4.6 ×250mm）with column temperature at 25℃, and the mobile phase was composed of 0.05 mol . L-1 sodium acetate （adjusted to pH 4.0 with orthophosphoric acid）-acetonitrile （40：60） with flow rate at 1 ml ·min- 1. The detection wavelength was at 283 nm and the sample size was 20μl. Results The liner range of naftidrofuryl oxalate was 10μg · ml-1-100 μg · ml-1 （r = 0. 9999）, and its average recovery was 99.75%, RSD=0.79% （n=6）. Conclusions This method is reliable, accurate, and it can be used as a quality control of naftidrofuryl oxalate coated pellets.