Determination of high molecular weight substance in Reduning Injection by size exclusion chromatography / 中草药

ABSTRACT

Objective: To establish a high performance size exclusion chromatography for the determination of high molecular weight substance in Reduning Injection. Methods: The chromatography on TSK G2000 SWxl column (300 mm × 7.8 mm, 5 μm) was used with 0.1% trifluoroacetic acid aqueous solution-acetonitrile (7030) as the mobile phase at a flow rate of 0.7 mL/min, and the detection wavelength was at 214 nm at column temperature of 30°C. Results: In the range of 3108-66446, the molecular weight was linear with retention time (r=0.9920). The high molecular weight substances were not detected in 11 batches of Reduning Injection. Conclusion: This method is simple, quick, and accurate, and suitable for the quality control of Reduning Injection.