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目的建立反相高效液相色谱法测定成骨生长肽鼻喷剂含量的方法。方法KromsoilC18柱(250mm×4.6mm,5μm);流动相为乙腈A(含0.1%三氟乙酸)和蒸馏水B(含0.1%三氟乙酸)(采用梯度洗脱,比例为0～25min时A从20%～30%);流速为1.0mL·min-1,柱温35℃,检测波长210nm。结果反相高效液相色谱法测定成骨生长肽的线性范围为0.05～1.0mg·mL-1(n=3),线性方程为Y=14294X+90.2,r=0.9998;最低检测限为6μg·mL-1;日内、日间精密度良好(RSD<2.5%);方法回收率为(100.6±1.6)%。结论本方法专属性强,重复性好,回收率高,可用于该制剂的含量控制。
Objective To establish a method for the determination of the content of osteogenic growth peptide nasal spray by reversed-phase high performance liquid chromatography. Methods Kromsoil C18 column (250mm × 4.6mm, 5μm) was used. The mobile phase consisted of acetonitrile A (containing 0.1% trifluoroacetic acid) and distilled water B (containing 0.1% trifluoroacetic acid) 20% ~ 30%). The flow rate was 1.0 mL · min-1, the column temperature was 35 ℃ and the detection wavelength was 210 nm. Results The linear range of the osteogenic growth peptide was 0.05-1.0 mg · mL-1 (n = 3). The linear equation was Y = 14294X + 90.2, r = 0.9998. The detection limit was 6μg · mL-1. The intra-day and inter-day precision was good (RSD <2.5%). The recovery rate was (100.6 ± 1.6)%. Conclusion The method is highly specific, reproducible and has high recovery rate and can be used for content control of the preparation.