HPLC法测定奥曲肽的含量及其有关物质

Determination of the Content of Octreotide and Its Related Substances by HPLC

目的:建立高效液相色谱法测定奥曲肽的含量及其有关物质。方法:采用Lichrospher-C_(18)色谱柱(200mm×4.6mm,5μm),流动相A为含0.1％三氟乙酸的水溶液,流动相B为含0.1％三氯乙酸的乙腈溶液,采用梯度洗脱,流动相B在20min内从20％升至40％,流速1.5mL·min^(-1),检测波长215nm。结果:HPLC法测定的线性范围为40.8～142.8μg·mL^(-1),r=0.9999,最低检测限量为1ng,本方法重复性和精密度良好(RSD<2％)。结论:采用HPLC梯度洗脱法测定奥曲肽的含量及其有关物质,方法简便,结果准确。

Objective: To establish HPLC method for determination of the octreotide content and its related substances. Methods: The column; Lichrospher - C18 column (200 mm × 4. 6 mm, 5 μm). The mobile phase A; 0.1% trifluroacetic in water; the mobile phase B; 0.1 % trifluroacetic in acetonitrile. The gradient elution method was used that the mobile phase B was increased from 20% to 40% in twenty minutes. The flow rate: 1.5 mL · min-1. The detection wavelength; 215 nm. Results: There is a good linear relationship with the range of 40. 8 - 142. 8 μg · mL-1 (r = 0. 999 9). The repeatability and precision of the method is good ( RSD < 2% ). Conclusion: The method to determine the content and the related substances of octreotide by HPLC is sim-ple and accurate.