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Development And Validation Of Stability Indicating HPLC Methods For Phytotherapeutics | 10243
ISSN: 2155-9872
Journal of Analytical & Bioanalytical Techniques
Open Access
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Herbal drugs and their derivatives, as well as herbal medicinal products represent a challenge in the analytical field, not only
due to the complexity of their composition in active substances, at different concentration levels, but also from the point of
view of stability of such active ingredients. The biological effect of an herbal medicine is resulted by the complex of constituents
more than by the major and isolated active ingredients, thus their technological processing must preserve as much as possible its
overall composition. Therefore an appropriated analytical method must be selective and allow monitoring the overall composition
of raw materials, intermediate products and the final formulations of herbal medicines. After the processing of the extractive
solutions by techniques involving heat, for instance by spray drying, commonly used to produce dried extract, it is common to
observe the loss of a particular biological activity and the maintenance of other biological activities. A detailed inspection on
chromatographical profile of the samples, before and after the heat treatment, may reveal what substances may play a role in
the biological effect studied, though sometimes it will be necessary to couple techniques to reveal the differences in the sample
composition. However, to understand which substances play a role in the biological effect, a previous submission to stress tests to
simulate or predict the sample behavior is useful. Monitoring its concentration level and its liability simulating stress conditions
to which the samples will be submitted is very important in the development of analytical methods. The stress conditions must
be well planned to closely simulate the technological processes employed in producing intermediate and finished products and
also in the physiology conditions of administrations (as example the gastrointestinal pH). In addition, the lyotropic studies
parameters (as example, dissolution medium, apparatus, rotation) must be established to develop a discriminative dissolution
method for oral dosage forms based on phytomedicine. In this way, which are the substances that should be bioavailable and
measured to construct the dissolution profile? To understand what substances are involved in the aimed biological activity it is
essential to correlate it to the number and level of constituents in the original and stressed samples.
Biography
Tania Mari Bell? Bresolin has completed her Ph.D. at the age of 32 at the Federal University of Paran? (Brazil) with a sandwich in CERMAV
(Centre de Recherche sur les Macromol?cules V?g?tales), Grenoble, France. She is the Coordinator of Post-Graduation Program of Pharmaceutical
Sciences, at University of Valley of Itaja? (Brazil). She has published more than 40 papers in reputed journals, 2 books and 4 chapters of books and
is serving as referee member of repute journals. She has 4 patent applications, being 2 in partnership with the pharmaceutical industry, in the field of
phytotherapeutics. She has experience with drug development, HPLC development and analytical validation, and biopolymers.
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