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Pharmacokinetics of Andrographolide Sodium Bisulphite and its Related Substance in Rats by Liquid Chromatography–Tandem Mass Spectrometry

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Abstract

Acute renal failure caused by Lianbizhi® injection can be attributed to andrographolide sodium bisulphite (ASB) and its main related substance RS413. For the safety evaluation of ASB and RS413, the pharmacokinetics of both compounds in rats was investigated through a liquid chromatography-tandem mass spectrometry method. After a simple protein precipitation with methanol, ASB and RS413 with dehydroandrographolide as an internal standard in plasma were separated on a C18 column using gradient elution with methanol and water and detected in the negative selected reaction monitoring mode. The intra- and inter-day accuracies of the method varied from 96 to 107% over the concentration range of 10–1000 ng/mL. Precisions were within 7.8% and the extraction recoveries ranged between 71–99% without obvious matrix effects. The method was applied for the simultaneous quantification of ASB and RS413 in rats treated intravenously with ASB and RS413 at the dose of 80 mg/kg for the first time.

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    Authors and Affiliations

    1. Beijing Advanced Innovation Center for Food Nutrition and Human Health, Beijing Technology and Business University, 100048, Beijing, China

      Shuang-Qing Zhang & Xiuting Li

    2. National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, 100050, Beijing, China

      Shuang-Qing Zhang

    3. Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, 100038, Beijing, China

      Xinghe Wang

    4. Hubei Provincial Key Laboratory of Yeast Function, 443003, Yichang, China

      Yan Zhang

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    1. Shuang-Qing Zhang
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    2. Xinghe Wang
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    3. Yan Zhang
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    4. Xiuting Li
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    Correspondence to Shuang-Qing Zhang or Xiuting Li.

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    Zhang, SQ., Wang, X., Zhang, Y. et al. Pharmacokinetics of Andrographolide Sodium Bisulphite and its Related Substance in Rats by Liquid Chromatography–Tandem Mass Spectrometry. J Anal Chem 75, 1033–1037 (2020). https://doi.org/10.1134/S1061934820080183

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    • DOI: https://doi.org/10.1134/S1061934820080183

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