HPLC-ELSD Detection of Macromolecular Substances in Compound Kushen Injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a high-performance liquid gel chromatography (HPLC-ELSD) method for the detection of macromolecular substances in Compound Kushen injection. METHODS: TSKgel G2000SWXL (7.8 mm×300 mm, 5 μm) chromatographic column was used. A 20 mmol•L-1 ammonium acetate aqueous solution was used as the mobile phase. The column temperature was maintained at 25℃, the flow rate was 0.8 mL•min-1, and the parameters of the evaporative light detector (drift tube temperature 55℃, atomization temperature 55℃, nitrogen flow rate, 1.8 L•min-1), a method for detecting macromolecular substances was established, and eleven batches of Compound Kushen injection were tested for macromolecular substances. RESULTS: No macromolecular substances was detected in the eleven batches of Compound Kushen injection, indicating that after the step-by-step removal of impurities, macromolecular substances have been removed from the finished Compound Kushen injection products. CONCLUSION: This method is simple and fast, which can be used for the detection of macromolecular substances in Compound Kushen injection, it provides a basis for improving the quality standards of Compound Kushen injection.