摘要
目的:建立重组人胰高血糖素类多肽-1(7-36)[rhGIP-1(7-36)]原料及制剂的肽含量和有关物质的RP-HPLC测定方法。方法:采用ODS柱(250 mm×4.6 mm,5μm),以0.2 mol·L-1硫酸钠缓冲液(用乙醇胺调节pH至2.3)-乙腈(82:18)为流动相A,50%乙腈为流动相B,调整流动相的比例[A-B(55:45)]使主峰的保留时间在20-25 min,流速为1.0 mL·min-1,检测波长214 nm,柱温为45℃。结果:线性范围为0.6-18.6μg,制剂平均回收率为96.01%,原料和制剂精密度试验RSD分别为0.15%和0.25%,最低检测限6.25 ng。结论:本方法可用于rhGLP-1(7-36)原料及其制剂的肽含量和有关物质的测定,具有准确、简便、快速、灵敏的特点。
Objective: To establish a RP - HPLC method for determination of recombinant human glucagon - like peptide -1(7-36 )[rhGLP-1(7-36)],content of rhGLP - 1 (7 - 36 ) for injection and related substances. Methods: A ODS column(250 mm×4. 6 mm,5μm) was used,the mobile phase A were 0. 2 mol·L-1 sodium sul-fate buffer(adjusted to pH 2. 3 with ethanolamine) - acetonitrile(82: 18) and mobile phase B consisted of 50% acetonitrile, adjusted the ratio of mobile phase to keep the retention time of rhGLP -1(7-36) and related compounds between 20 to 25 minutes [A-B( 55: 45)] , the flow rate was 1 mL·min-1 and the detection wavelength was 214 nm,the column temperature was 45℃. Results:The calibration curves were linear in the range of 0. 6-18. 6μg. The recovery of rhGLP-1 (7-36) for injection was 96.01 % , the LOD was 6. 25 ng. Conclusion: The method can be used analysis of rhGLP -1(7 -36)and its related substances,it is accurate,simple and quick.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第2期187-189,共3页
Chinese Journal of Pharmaceutical Analysis
