Ingredient Analysis

Simultaneous determination of seven components in Xintong granules by UPLC wavelength switching method*

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  • 1. Lunan Pharmaceutical Group Co., Ltd., State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Linyi 276006, China;
    2. Lunan Hope Pharmaceutical Co., Ltd., Linyi 276006, China

Received date: 2023-01-14

  Online published: 2024-06-24

Abstract

Objective: To establish a quantitative method for simultaneous determination of puerarin, daidzin, 2, 3, 5, 4'-tetrahydroxystilbene-2-O-β-D-glucoside, naringin, salvianolic acid B, icariin and tanshinone ⅡA in Xintong granules. Methods: UPLC wavelength switching method was adopted in the assay. The chromatographic analysis was performed on a Waters CORTECS® C18 column (50 mm×4.6 mm, 2.7 μm), and the mobile phase was acetonitrile (A) -0.1% phosphoric acid solution (B) with gradient elution. The flow rate was 0.3-0.5 mL·min-1, and the column temperature was 35 ℃. The detection wavelength was chosen at 250 nm for puerarin and daidzin during 0-15 min, 320 nm for 2, 3, 5, 4'-tetrahydroxystilbene-2-O-β-D-glucoside during 15-23 min, 283 nm for naringin and salvianolic acid B during 23-36 min, and 270 nm for icariin and tanshinone ⅡA during 36-56 min. Resluts: Satisfactory linearities of puerarin, daidzin, 2, 3, 5, 4'-tetrahydroxystilbene-2-O-β-D-glucoside, naringin, salvianolic acid B, icariin and tanshinone ⅡA were in the ranges of 34.43-344.32 μg·mL-1 (r=0.999 9), 8.33-83.28 μg·mL-1 (r=0.999 9), 1.48-14.76 μg·mL-1 (r=0.999 9), 2.37-23.68 μg·mL-1 (r=0.999 8), 14.58-145.76 μg·mL-1 (r=0.999 9), 1.86-18.56 μg·mL-1 (r=0.999 9) and 0.62-6.24 μg·mL-1 (r=0.999 9), respectively. The average recoveries (n=6) were 98.9%, 98.3%, 98.1%, 98.2%, 98.6%, 99.1% and 98.2%, respectively, with RSDs less than 1.5%. The contents ranges of puerarin and other 6 components in 24 batches of Xintong granules samples were 7.813-8.338 mg·g-1, 1.834-2.119 mg·g-1, 0.336-0.405 mg·g-1, 0.611-0.764 mg·g-1, 3.018-3.753 mg·g-1, 0.445-0.554 and 0.139-0.174 mg·g-1, respectively. Conclusion: The UPLC wavelength switching method established is rapid, simple and accurate, which can be used for the quality control of Xintong granules.

Cite this article

ZHUANG Hui-fang, YUAN Xiao-mei, ZHUANG Jian-lin, ZHAO Sen-sen, FAN Jian-wei, ZHANG Gui-min . Simultaneous determination of seven components in Xintong granules by UPLC wavelength switching method*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(8) : 1284 -1290 . DOI: 10.16155/j.0254-1793.2023.08.03

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