CAJ | 학술논문

目的：建立气相色谱（GC）法测定重组人胰高血糖素类多肽-1（rhGLP-1）（7-36）注射液中丙二醇的含量。方法采用石英毛细管柱（30 m×320μm，0.5μm），载气为N2，流速：1ml/min，进样口温度为230℃，检测温度为250℃，进样量为1μl；结果丙二醇的浓度在0.5～1.5 mg/ml范围内与峰面积有良好的线性关系（r=0.9991），平均回收率（n=9）为100.2%；不同色谱条件下，耐用性良好，RSD均＜2.0%。结论该方法快速、简便、重复性好，适用于rhGLP-1（7-36）注射液中丙二醇含量的测定。
목적：건립기상색보（GC）법측정중조인이고혈당소류다태-1（rhGLP-1）（7-36）주사액중병이순적함량。방법채용석영모세관주（30 m×320μm，0.5μm），재기위N2，류속：1ml/min，진양구온도위230℃，검측온도위250℃，진양량위1μl；결과병이순적농도재0.5～1.5 mg/ml범위내여봉면적유량호적선성관계（r=0.9991），평균회수솔（n=9）위100.2%；불동색보조건하，내용성량호，RSD균＜2.0%。결론해방법쾌속、간편、중복성호，괄용우rhGLP-1（7-36）주사액중병이순함량적측정。
Objective To establish a method to detect the content of propylene glycol in the recombinant human glucagon-like peptide-1(rhGLP-1)(7-36) injection by gas chromatography(GC). Methods GC was performed using a quartz capillary column (30 m ×320 μm,0.5 μm) with the mobile phase of N2 and inlet temperature of 230℃ at the flow rate of 1ml/min and column temperature of 250 ℃, the injection volume was 1μl. Results The calibration curve was linear within the range of 0.5-1.5 mg/ml, r=0.9991. The average recovery rate was 100.2%; under different chromatographic conditions, the method had good stability, RSD was less than 2.0%. Conclusion This method is simple, accurate and reproducible, and can be applied in the determination of propylene glycol content in rhGLP-1(7-36) injection.