Determination of propylene glycol content in recombinant human glucagon-like peptide-1(7-36) injection by GC / 国际药学研究杂志

ABSTRACT

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.