The overall quality control of xianling gubao capsules based on hplc-uvd-elsd fingerprint and simultaneous determination of main representative components / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish the fingerprint of Xianling Gubao Capsules (XLGB) by multi-wavelength HPLC-UVD-ELSD and determine the main representative components simultaneously, in order to provide reference for the overall quality control of XLGB.METHODS: The separation was developed on Poroshell 120 EC-C18 column (4.6 mm×100 mm, 2.7 μm) by gradient elution with methanol-water at 240, 270 and 334 nm, the temperature of drift tube was maintained at 105 ℃ and the carrier gas flow rate was 2.0 L•min-1. An HPLC-UVD-ELSD fingerprint of XLGB was set up, and 15 batches of XLGB were evaluated by similarity assay. Furthermore, the contents of the main representative components were determined on the premise of small disparities between batches. RESULTS: The multi-wavelength HPLC-UVD-ELSD fingerprint of XLGB was established with good separation, and six chemical components were determined simultaneously. Thirty-one main characteristic peaks from six herbs of XLGB were chemically identified and 26 main characteristic peaks were assigned to individual herbs. The similarity of 15 batches of XLGB was about 0.943 to 0.997. Moreover, good linear relationships were found (r=0.999 0-0.999 6), and the average recovery rates were 98.5%-104.9%. CONCLUSION: The method can be used for the overall quality control of XLGB with good specificity and high efficiency and is close to the actual production, which is promising to be further improved to be used as an industry internal control standard.