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Original Article




              Alternative to the Thai Herbal

              Pharmacopoeia Method for Quality

              Control of Andrographis Capsules




              Triporn Wattananat*
              Supanee Duangteraprecha
              Jiranuch Jamtaweekul
              Prapapun Sukphan










                 Abstract
                         Rationale and Objective:  Reflux extraction is the standard sample preparation method
                     described in the Thai Herbal Pharmacopoeia (THP) for the assay of andrographolide content in
                     both Andrographis herbal material and capsules, and has been used since 1995. The disadvan-
                     tages of this method are the consumption of large amounts of volatile and hazardous organic
                     solvents, low extraction efficiency and a time-consuming process. The objectives of this study
                     were to compare the extraction efficiency of ultrasonication and reflux extraction methods and to
                     propose an alternative to the current THP method for quality control of Andrographis capsules.
                         Methodology:  Optimization of extracting solvent and sonication time were investigated.
                     The best condition was further used for comparison of the extraction efficiency with reflux ex-
                     traction. A total of 30 different lots of Andrographis capsules were tested. The analytical method
                     as described in the THP was revalidated to ensure method performance and data integrity after
                     the sample preparation had been changed.
                         Results:  Ultrasonication with 50% methanol for 15 minutes gave the highest
                     andrographolide content extracted. Changes in sample preparation did not affect the analytical
                     method performance. The contents of andrographolide extracted using ultrasonication were com-
                     parable and in most cases they were even higher than those obtained from the reflux method.
                         Discussion and Conclusion:  Ultrasonication is a more efficient, rapid and convenient method
                     and can be used as an alternative sample preparation method to the current monographs in THP
                     for the quality control of both Andrographis herbal material as well as medicinal products.

                     Keywords: ultrasonication, andrographis capsules, quality


              Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health, Nonthaburi 11000, Thailand.
              *Corresponding author: triporn.w@dmsc.mail.go.th Received date 10/06/16 ■ Accepted date 14/09/16

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