Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms

Abstract

How to cite this article: Demirbolat İ, Kartal M. Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. J Res Pharm. 2019; 23(4): 689-696. ABSTRACT:Premenstrual syndrome (PMS) is a common condition that affects 90% of menstruating women on emotions, behaviours and physical health. Vitex agnus-castus L. also known as chasteberry or chaste tree is long being used for its health benefits on feminine problems like PMS and hyperprolactinemia. There are also some prescription medicines to ease the symptoms of PMS. While dietary supplements containing medicinal plants could be found everywhere with the lack of quality and standardisation, there are only a few registered traditional herbal medicinal products available on the market containing agnus-castus fruit extract. In this study we developed a stable film coated oral formulation and fully validated the analytical methods to quantify the extract in dosage forms to fulfil the requirements of CTD module 3 while registering the traditional herbal medicinal product according to European Union legislations. 694 Limit of detection and limit quantification (LOD and LOQ)Analytical procedures for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products are classified as category 1. United States Pharmacopoeia states that LOD and LOQ test data elements are not required for this category [15]. RobustnessThe robustness of an analytical procedure is the measure of method capacity to remain stable with relatively small amount of changes in method parameters [15]. Robustness test were evaluated by increasing the flow rate at 10% and increasing the temperature of the column for 5 0 C. 696Author contributions: Concept -İ.D., M.K.; Design -İ.D., M.K.; Supervision -M.K.; Materials -İ.D., M.K.; Data Collection and/or Processing -İ.D., M.K.; Analysis and/or Interpretation -İ.D., M.K.; Literature Search -İ.D., M.K.; Writing -İ.D., M.K.; Critical Reviews -İ.D., M.K. Conflict of interest statement:The authors declared no conflict of interest.

A Very Rare Cause of Bicytopenia; The Use of Vitex Acnu Castus

“…In the European Union herbal monograph, the posology commends that products containing VAC dry extracts are used for irregular menstruation, premenstrual syndrome and mastalgia at 4 to 20 mg/day. These dry extracts are standardized in the European Pharmacopoeia (EP) to contain not less than 0.01% casticin in the extract (3).…”