HPLC测定沙喹那韦的含量及其有关物质

Determination of Saquinavir and Its Related Substances by HPLC

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。

OBJECTIVE To develop a HPLC assay for the detemfinafion of saquinavir and its related substances.METHODS The separation was performed on an Alhima C8 column （ 4.6 mm× 250 mm, 5 tan）, 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 nm. 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.