RP-HPLC测定成骨生长肽鼻喷剂含量

Determination the Content of Osteogenic Growth Peptide Nasal Spray by RP-HPLC

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 RP-HPLC method for determination of osteogenic growth peptide（OGP） nasal spray. METHODS The Kromsoil C18 column （250 mm × 4.6 mm, 5 μm） was used, the acetonitrile-water with 0.1% trifluoroacetate as mobile phase （gradient elution 0-25 min, acetonitrile： 20%-30%）, the flow rate was 1.0 mL·min^-1, the column temperature was 35 ℃, the detection wavelengh was 210 nm. RESULTS The linear ranges of OGP was at 0.05-1.0 mg·mL^-1, the linear equation was Y=14 294X＋90.2, the correlation coefficient was 0.999 8, the least detective limit was 6 μg·mL^-1, the recovery of the method was （100.6± 1.6）% and the intra-day and inter-day RSD were less than 2.5%. CONCLUSION The method is reliable, accurate and sensitive. The results show that method can be used to control quality of products.