Isolation of Vitexin from Vitex Negudo of Assam and Development of Its Topical Formulation and Determine Acute Dermal Toxicity Study in Wistar Rats

Abstract

Objective: To isolate vitexin from Vitex Negundo and development of its topical formulation and determine acute dermal toxicity study in wistar rats.

Methods: The flavonoid content of the leaves of Vitex negundo was determined by systematically extracting them using hexane, chloroform, ethyl acetate, methanol, and water using a soxhlet apparatus. After loading the methanol extract into the column chromatography, vitexin was separated, purified and identified by FTIR, NMR,DSC, MS and HPTLC. The purity of the vitexin was evaluated using HPLC. The isolated vitexin was incorporated to topical drug delivery vehicle cream and gel. The optimized formulation was evaluated physiochemically and acute dermal toxicity of optimized cream was determined as per OECD guideline (402) in three groups of wistar rats.

Results: Based on the findings, methanolic extract of Vitex negundo depicted the existence of a significant amount of flavonoids with 50-60% yield of vitexin. From the HPLC study's findings, vitexin derived from Vitex negundo leaves was demonstrated to be more pure than vitexin found in other sources. Vitexin was incorporated in topical drug delivery vehicle as cream. Vitexin cream exhibited acceptable stability, viscosity and physical properties. Topical application of vitexin cream (10%) was applied to rat skin to determine acute dermal toxicity.

Conclusions: 10% cream formulation of vitexin did not cause acute dermal toxicity to wistar rats. Results of the analysis indicate that isolated vitexin may be regarded as non- toxic and generally safe.