Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF STIGMASTEROL AND EMBELIN

Vineeta V. Khanvilkar*, Preeti N. Gunjal, Dr. Vilasrao J. Kadam

ABSTRACT

Standardization of herbal formulation is essential in order to assess the quality, purity, safety and efficacy of drugs. The present work describes a chromatographic method for simultaneous estimation of stigmasterol and embelin which can be further applied for standardization of chopchinyadi churna. Chopchinyadi churna is a polyherbal formulation prescribed for treatment of skin diseases. This preparation also works well in rheumatoid arthritis and gout. It contains Smilax china and Embelia ribes as major components in formulation from which stigmasterol and embelin respectively were used as marker compounds. A simple, rapid, precise, accurate, and reproducible High Performance Thin Layer Chromatographic (HPTLC) method was developed. The separation was performed on TLC aluminium plates precoated with silica gel 60 F254, wherein good separation was achieved in the mobile phase of Toluene: ethyl acetate: methanol: formic acid (6:2:1:1 v/v/v/v). Densitometric scanning for stigmasterol and embelin was done using single wavelength i.e 212nm. The retardation factor(Rf) value of stigmasterol and embelin was found to be 0.63+0.02 and 0.45+0.02, respectively. The developed method was validated as per ICH guidelines and applied for standardization of chopchinyadi churna from in-house and marketed formulations.

Keywords: Chopchinyadi churna, stigmasterol, embelin, HPTLC, polyherbal formulations, ICH.