高效液相色谱用于参麦注射液人参皂苷的含量测定和批次一致性考察

Determination of ginsenosides and assessment of the batch-to-batch consistency of Shenmai injection by HPLC

目的 用高效液相色谱法测定参麦注射液中人参皂苷Rg1和Rb1的含量 ,并用所检测到的指纹图谱考察参麦注射液不同批次产品内在质量的一致性。方法 采用汉邦C18(5 μm ,2 5 0mm× 4 .6mm)色谱柱 ,流动相A为 5 0mmol·L-1KH2 PO4溶液 ,B为乙腈 水 (80∶2 0 ) ,pH =3.5梯度洗脱 ,流速 1mL·min-1,检测波长为 2 0 2nm ,柱温为 4 0℃。结果 人参皂苷Rg1和Rb1的加样回收率 >99% ,RSD <1.2 % ,人参皂苷Rg1和Rb1分别在 4 .2 0～ 4 2 .0和 3.30～ 33.0 μg范围内线性关系良好 ,色谱指纹图谱中分离出 30多个峰。结论 将指标性成分人参皂苷Rg1和Rb1的含量测定与色谱指纹图谱比较分析相结合 ,可提高参麦注射液的内在质量控制水平。

OBJECTIVE: To establish a HPLC assay for the determination of the ginsenosides Rg1 and Rb1 and assess the batch-to-batch consistency of Shenmai injection by chromatographic fingerprint. METHODS: The chromatographic separation was performed on a Hanbang Hypersil C18 column (5 μm, 4.6 mm × 250 mm). A linear gradient elution of A (50 mmol&middotL-1 KH2PO4) and B (acetonitrile-wate = 80:20) was used. The flow rate was 1 mL&middotmin -1. The detection wavelength was set at 202 nm, and the column temperature was 40°C. RESULTS: The average recoveries of ginsenosides R g1 and Rb1 were above 99% with RSD less than 1.2%. The response was linear over the range of 4.20-42.0 μg for Rg1 and 3.30-33.0 μg for Rb1, respectively. Over 30 ginsenosides were separated by the chromatographic fingerprints. CONCLUSION: Combining the determination of the ginsenosides Rg1 and Rb1 with the comparison of chromatographic fingerprints, the quality control of Shenmai injection can be assessed.