Composition uniformity indicating assay of traditional Lithuanian multi-ingredient phytopreparation

Abstract

Phytopharmaceutical case introduces of the way to scientific based modernisation of traditional multi-ingredient herbal preparations. ‘<i>Trejos</i> <i>devynerios’</i> is a well recognized Lithuanian medicine of particularly deep consumption traditions which contains 27 herbal raw materials. The archive sources of the preparation formula date back to the times of the United Republic of Poland and Lithuania (15-18^th centuries). The contemporary quality assurance of product containing scores of active ingredients is very complicated, because each of plant ingredients is source of various phytochemicals. Carrying out modernization of multi-ingredient product the common markers in the aglycone form (quercetin, luteolin and emodin) were reasonably selected to control the composition uniformity of product. Modernisation of quality assurance and control also includes the development and validation of composition uniformity indicating assay of selected markers. The validation study conform the specificity and precision and l<span style="mso-bidi-font-weight:bold">inearity proved in the application <span style="mso-bidi-font-weight:bold">range that exceeds the reliable one. After evaluation of appropriate markers and validation of suitable analytical method, justification of lowest quantitative limits criteria for the release specification sheet was substantiated. Finally, the gained specification limits were applied to release of oral solution.

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