盐酸沙丙蝶呤片有关物质的HPLC法测定

Determination of Related Substances in Sapropterin Dihydrochloride Tablet

建立了高效液相色谱法测定盐酸沙丙蝶呤片中的有关物质。采用键合磺酸基阳离子惰性硅胶为填充剂的色谱柱,流动相为50 mmol/L磷酸二氢钾溶液-乙腈(80∶20),检测波长220 nm。结果显示,主峰与其他杂质峰均分离完全,盐酸沙丙蝶呤(1)、L-生物蝶呤(2)、7,8-二氢生物蝶呤(3)、蝶呤(4)、(6S)-四氢生物蝶呤(5)和5,6,7,8-四氢蝶呤(6)均在相应浓度范围内线性关系良好,5个杂质的平均回收率分别为102.55%、100.03%、99.74%、98.30%和99.88%。

An HPLC method was established for the determination of related substances in sapropterin dihydrochloride tablet.A Spherisorb SCX column was used,with the mobile phase of 50 mmol/L monopotassium-acetonitrile at the detection wavelength of 220 nm.The results showed that the main peak and other impurity peaks were separated completely and they were linear for sapropterin dihydrochloride(1),L-biopterin(2),7,8-dihydrobiopterin(3),pterin(4),6S-tetrahydro-L-biopterin(5)and 5,6,7,8-tetrahydropterin dihydrochloride(6)in the range of concentrations.The recoveries of five impurities were 102.55%,100.03%,99.74%,98.30%and 99.88%,respectively.