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.
ABSTRACT
Aconiti Lateralis Radix Praeparata (Fuzi) is a commonly used traditional Chinese medicine in clinic for its potency in restoring yang and rescuing from collapse. Aconiti alkaloids, mainly including monoester-diterpenoidaconitines (MDAs) and diester-diterpenoidaconitines (DDAs), are considered to act as both bioactive and toxic constituents. In the present study, a feasible, economical, and accurate HPLC method for simultaneous determination of six alkaloid markers using the Single Standard for Determination of Multi-Components (SSDMC) method was developed and fully validated. Benzoylmesaconine was used as the unique reference standard. This method was proven as accurate (recovery varying between 97.5%-101.8%, RSD 0.999 9) over the concentration ranges, and subsequently applied to quantitative evaluation of 62 batches of samples, among which 45 batches were from good manufacturing practice (GMP) facilities and 17 batches from the drug market. The contents were then analyzed by principal component analysis (PCA) and homogeneity test. The present study provided valuable information for improving the quality standard of Aconiti Lateralis Radix Praeparata. The developed method also has the potential in analysis of other Aconitum species, such as Aconitum carmichaelii (prepared parent root) and Aconitum kusnezoffii (prepared root).