HPLC测定沙喹那韦的含量及其有关物质

 目的建立测定沙喹那韦含量与有关物质的高效液相色谱法。方法采用Alltima C₈色谱柱(4.6 mm×250 mm,5 μm)。流动相:0.02 mol·L^-1磷酸盐缓冲液(pH 6．7)-乙腈(40:60),流速:1.0 mL·min^-1。检测波长:240,220 nm。结果在上述色谱条件下,7种中间体和各降解产物均可与沙喹那韦主峰良好分离。HPLC测定的线性范围为16.44～61.64 mg·L^-1,r=0．999 9,沙喹那韦的最低检测限为0.41 ng,方法的精密度为0.49％,平均回收率为100.2％。结论采用HPLC测定沙喹那韦的含量及其有关物质,方法简便,结装准确可靠。

Determination of Saquinavir and Its Related Substances by HPLC

OBJECTIVE To develop a HPLC assay for the determination of saquinavir and its related substances. METHODS The separation was performed on an Alltima C₈ column (4.6 mm×250 mm,5 μm), and the mobile phase consisted of acetonitrile and 0.02 mol·L^-1 phosphate buffer solution (pH 6.7) (60:40) at the flow rate of 1.0 mL·min^-1.The detection was carried out at 240 and 220 ran.RESULTS An excellent separation was achieved for saquinavir and its related substances.The assay was validated in the concentration range of 16.44～61.64 mg·L^-1(r=0.999 9).The method had a detection limit of 0.41 ng for saquinavir.The precision was 0.49% , and the average recovery was 100.2% .CONCLUSION The method developed is successfully used to determine saquinavir and its related substances.