RP-HPLC法测定酪丝亮肽及其制剂的含量和有关物质

RP-HPLC Determination of the Content and the Related Substances of Tyroserleutide and Its Preparation

目的:建立高效液相色谱法测定酪丝亮肽及其制剂的含量和有关物质。方法:采用C18色谱柱(5μm,4.6 mm×250mm);流动相A为0.2 mol·L-1硫酸钠缓冲液(pH 2.3),B为乙腈-水(90:10);流速1.0 mL·min-1,梯度洗脱;检测波长:220 nm;进样量:20μL;柱温:30℃。结果:方法的线性范围为0.31-8.29μg(r=0.9999);最低检测限0.2 ng;精密度的RSD为0.11%(n=7);制剂的平均加样回收率为99.1%(n=9)。结论:方法简便灵敏,结果准确可靠,可用于原料及制剂的含量测定及有关物质检查。

Objective:To establish a RP- HPLC method to determine the content and the related substances of ty roserleutide and its preparation. Method:C18 column(5μm,4. 6 mm±250 mm) was used at 30℃. The mobile phase was consisted of 0. 2 mol·L -1 sodium sulfate buffer solution ( adjusted pH to 2. 3 with phosphoric acid) as mobile phase A and acetonitrile - water(90:10) as mobile phase B with UV detection at 220 nm. The flow rate was 1.0 mL·min -1 with linear gradient. The injection volume was 20μL. Results:The linear range of the method was 0. 31 -8. 29μg (r = 0. 9999); the limit of detection was 0. 2 ng; the precision RSD was 0. 11 % (n = 7); the average recovery of the preparation was 99. 1% (n =9). Conclusion:The method is simple, sensitive, accurate and can be used for the determination of tyroserleutide and its preparation.