Research articles
ScienceAsia 52 (2026): 1-9 |doi:
10.2306/scienceasia1513-1874.2026.056
Quality and safety evaluation of Andrographis products using
a USP-modified HPLC-PDA single-standard approach
Supawadee Seubsasanaa, Chitsanupong Chitsawata, Witchayaporn Poonkerda,
Weerachart Kajornjarupana, Bhanuz Dechayontb, Rungravi Temsiririrkkula, Nipapan Malisornb,*
ABSTRACT: Andrographis paniculata (Burm.f.) Wall. ex Nees is widely used in traditional medicine, particularly in
Asia, due to its immunomodulatory, anti-inflammatory, and antiviral properties. Andrographolide (AD) and 14-deoxy
11,12-didehydroandrographolide (14-DAD)arekeyditerpenelactonescommonlyusedasmarkersforqualityandsafety
evaluation. This study aimed to evaluate the quality and safety of fifteen commercially available Andrographis products
using a validated HPLC-PDA method modified from the USP 43?NF 38monograph. Allparameters,includingspecificity,
linearity and range, accuracy, precision, and the limit of quantitation, met all requirements in accordance with ICH
Q2(R2) guidelines. Quantitative analysis showed that AD was present in all samples, ranging from 0.38% to 5.08%
(w/w), of which two products failed to comply with pharmacopeial specifications. Based on their recommended daily
dose, six products contained insufficient amounts of their active ingredients to achieve the therapeutic effect. Notably,
14-DAD, avasodilator, was detected in all samples. Among these, eleven products exhibited high levels of 14-DAD, with
eight samples (53.3%) exceeding the USP 43?NF 38 limit and three reaching borderline levels. These findings raise
significant safety concerns, particularly regarding cardiovascular risk associated with 14-DAD exposure. In conclusion,
many products do not conform to the established quality and safety standards. The validated HPLC-PDA method
developed in this study provides a reliable and practical approach for the routine quality control and standardization
of Andrographis products.
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| a |
Faculty of Pharmacy, Thammasat University, Pathum Thani 12121 Thailand |
| b |
Faculty of Medicine, Thammasat University, Pathum Thani 12121 Thailand |
* Corresponding author, E-mail: mnipapan@tu.ac.th
Received 6 Oct 2025, Accepted 28 May 2026
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