反相离子对HPLC法测定替莫唑胺酯原料药的有关物质

目的: 建立替莫唑胺酯中有关物质的测定方法。 方法: 采用反相高效液相色谱法,色谱柱为Thermo 公司ODS-2HYPERSIL(250 mm×4.6 mm,5 μm);流动相为乙腈-0.04 mol·L^-1醋酸钠与0.01 mol·L^-1醋酸铵混合溶液(含0.01 mol·L^-1辛烷磺酸钠,pH=2.5)(35∶ 65);流速1.0 mL·min^-1;检测波长为254 nm。 结果: 替莫唑胺酯质量浓度在1.0~50.0 μg·mL^-1内,线性关系良好(r=0.9998)。 结论: 本法简便、灵敏,重复性好,可用于替莫唑胺酯原料药中有关物质的限度检查。

Objective: To develop a method so as to determine the related substances in temozolomide hexyl ester. Methods: Thermo ODS-2HYPERSIL(250 mm×4.6 mm,5 μm)column was used,the mobile phase was composed of acetonitrile-0.01 mol·L^-1 sodium 1-octanesulfonate( pH=2.5)in 0.01 mol·L^-1 ammonium acetate and 0.04 mol·L^-1 sodium acetate mixed solution (35∶ 65),at a flow rate of 1 mL·min^-1 and the detect wavelength was 254 nm. Results: The linear calibration curves obtained in the concentration range of 1.0-50 μg·mL^-1(r=0.9998). Conclusion: This method is convenient,accurate,reproducible and suitable for the determination of the related substances in temozolomide hexyl ester.