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

关键词:  成骨生长肽  鼻喷剂  高效液相色谱法  含量测定

Key words:  osteogenic growth peptide  nasal spray  HPLC  determination

摘要:

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Kromsoil C18柱(250 mm×4.6 mm，5 μm)；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0～25 min时A从20%～30%)；流速为1.0 mL·min-1，柱温35 ℃，检测波长210 nm。结果反相高效液相色谱法测定成骨生长肽的线性范围为0.05～1.0 mg·mL-1 (n=3)，线性方程为Y= 14 294 X + 90.2，r=0.999 8；最低检测限为6 μg·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。

Abstract:

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.