Abstract
Andrographis paniculata is a herbal drug of Asian traditional medicine largely employed for the treatment
of several diseases. Recently, it has been introduced in Europe for the prophylactic
and symptomatic treatment of common cold and as an ingredient of dietary supplements.
The active principles are diterpenes with andrographolide as the main representative.
In the present study, an analytical protocol was developed for the determination of
the main constituents in the herb and preparations of A. paniculata. Three different extraction protocols (methanol extraction using a modified Soxhlet
procedure, maceration under ultrasonication, and decoction) were tested. Ultrasonication
achieved the highest content of analytes. HPLC conditions were optimized in terms
of solvent mixtures, time course, and temperature. A reversed phase C18 column eluted
with a gradient system consisting of acetonitrile and acidified water and including
an isocratic step at 30 °C was used. The HPLC method was validated for linearity,
limits of quantitation and detection, repeatability, precision, and accuracy. The
overall method was validated for precision and accuracy over at least three different
concentration levels. Relative standard deviation was less than 1.13%, whereas recovery
was between 95.50% and 97.19%. The method also proved to be suitable for the determination
of a large number of commercial samples and was proposed to the European Pharmacopoeia
for the quality control of Andrographidis herba.
Key words
Andrographis paniculata
- Acanthaceae - quality control - diterpenes - andrographolide - HPLC-DAD-ESI-MS
