Quality standard study of Sarcandrae Herba Dispensing Granules based on specific chromatogram and multiple ingredients determination / 中草药

ABSTRACT

Objective: To establish HPLC and multiple components determination method of Sarcandrae Herba Dispensing Granules (SHDG), in order to compare the difference of the quality in various SHDG samples and provide an effective method to ensure the quality of SHDG. Methods: HPLC-UV method was used to establish the characteristic chromatogram of SHDG, and acetonitrile-0.2% formic acid solution was used as the mobile phase with the gradient elution. The common peaks were identified by comparison with the reference standards and HPLC-Q/TOF. At the same time, the method for simultaneous determination of chlorogenic acid, isofraxidin, and rosmarinic acid was established with the same approach. Chemometrics software Chempattern was employed to analyze the data. Through cluster analysis and principal component analysis, different preparations from different manufacturers and different batches from the same manufacturer were classified, and the main components causing the differences were clarified. Results: The SHDG fingerprint was established to confirm and identify seven characteristic peaks, namely, neochlorgenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, isofraxidin, rosmarinic acid-4-O-β-D-glucoside, and rosmarinic acid. The main chromatographic peaks of SHDG can be completely separated within 55 min. There was a good linear relationship between the peak area and concentration of chlorogenic acid, isofraxidin, and rosmarinic acid. The average recovery rates were 98.92% (RSD 1.54%), 98.20% (RSD 1.12%), and 99.58% (RSD 1.12%), respectively. The chlorogenic acid content of 18 batches of samples was 0.33-1.39 mg/g, the content of isocyanidine was 1.31-2.74 mg/g, and the content of rosmarinic acid was 1.11-4.54 mg/g. The similarity between 18 batches of samples and the common mode was 0.688-0.992. There were certain differences in the content of chlorogenic acid, isofraxidin, rosmarinic acid in the SHDG of various batches and manufacturers. Conclusion: The proposed specific HPLC characteristic chromatogram and quantitation method of three components for SHDG offered more comprehensive reference for quality control of the crude drug.