Selection of Guanxin Suhe Pill reference preparation by internal standard quantified fingerprints method / 中草药

ABSTRACT

Objective: To establish the Guanxin Suhe Pill (GXSHP)-HPLC internal standard quantified fingerprints method (ISQFM) for selecting the reference preparation of GXSHP by ISQFM and providing the quality control method of reference preparation. Methods: Agilent Poroshell 120 SB C18 column (150 mm × 4.6 mm, 2.7 μm), 0.2% ethylic acid-water, and 0.2% ethylic acid-methanol were used as the mobile phases that were eluted with liner program. The flow rate was 0.5 mL/min, the UV absorbance was monitored at 275 nm by injecting 5 μL of the sample solution each time, and the column temperature was maintained at (25.00 ± 0.15)°C. The ISQFM was used to identify the quality and select the reference preparation. Results: The 36 common peaks were marked by choosing IS as the referential peaks and the quality of 12 batches of GXSHPs was identified by the ISQFM. The identification results were that the quality of five batches (S3, S5-S7, and S9) were best, four batches (S4, S8, S10, and S11) were better, two batches (S1 and S2) were good, and one batch (S12) was lower than good, according to the results of this method, S3, S5-S7, and S9 could be used as the reference preparation of GXSHPs. Conclusion: This method could reduce the use of reference substances and improve the accuracy of the measured results. The reference preparation of GXSHPs, which is selected by this method, could be used for the quality control of large quantities of GXSHPs with the great significance in practical production.