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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 a method for the determination of octreotide and its related substances by high performance liquid chromatography. METHODS: The mobile phase A was 0.1% trifluoroacetic acid in water and the mobile phase B was acetonitrile containing 0.1% trichloroacetic acid using a Lichrospher-C 18 column (200 mm × 4.6 mm, 5 μm) Off, mobile phase B in 20min from 20% to 40%, flow rate 1.5mL · min ~ (-1), the detection wavelength of 215nm. Results: The linear range of HPLC was 40.8 ~ 142.8μg · mL -1, r = 0.9999. The minimum detection limit was 1ng. The method was reproducible and accurate (RSD <2%). Conclusion: HPLC gradient elution method for the determination of octreotide content and related substances, the method is simple and accurate.