Establishment of HPLC fingerprint of Compound Shiwei Tablets and application of its preparation process / 中草药

ABSTRACT

Objective To establish an HPLC fingerprint determination method of Compound Shiwei Tablets (CST), and apply it to the quality control during its preparation. Methods Agilent 5 TC C18 (2) (250 mm × 4.6 mm, 5 μm) column was used for HPLC with a gradient elution of acetonitrile-0.2% phosphoric acid in mobile phase at a flow rate of 1.0 mL/min. The wavelength was 235 nm, the column temperature was 25 ℃, and the injection volume was 10 μL. A total of 14 batches of CST and three batches of CST intermediates (extracts and granules) were measured. Results A common pattern of HPLC fingerprints of CST was established, and 18 common peaks were demarcated and five of them were identified. The relative peak retention time RSD of each batch was 0.990. The similarity between the same batch of CST intermediate and its preparation was > 0.990, and the correlation was good. Conclusion The established HPLC fingerprint of CST is simple, effective, and reproducible, and can be applied to the quality control of intermediates in the preparation process of the preparations, which provides a basis for the overall quality control of CST.