Formulation, stability and analytical method validations of combined St. John's wort and valerian root dry extracts in solid oral dosage forms

Abstract

Minor depression and sleep disorders are common problems in modern societies. There are prescription medicines and herbal remedies to ease the symptoms. St. John's wort is often used to treat mild depression and valerian root is recommended as a sedative for centuries. Nowadays there is an increasing interest for herbal medicines and therefore the herbal products are becoming more and more popular. As dietary supplement retailers selling low quality products -or even don't contain what's claimed on the label- quality becomes the major concern. The legislation to conventional medicines applies to traditional herbal medicines too, which makes registered herbal medicines reliable in production and quality. A CTD application dossier which contains quality data in module 3 should be provided while registering a herbal medicine in EU. In this study we developed a stable formulation and validated two separate methods to quantify the herbal extract amounts in solid oral dosage forms which contains St. John's Wort and valerian dry extract as active ingredients to comply CTD module 3 requirements.