Screening of E-and Z-guggulsterones in the gum-resin exudates of some common plants and method validation in raw, extracted, and pharmaceutical formulations of Commiphora mukul by HPLC

摘要

Hypolipidemic agents, E-and Z-guggulsterones, are the biomarker compounds found in the gum-resin exudates of Commiphora mukul. Gum-Resin exudates of six common plants included Mangifera indica, Ficus religiosa, Delonix regia, Acacia nilotica, Abies balsamea, and Commiphora stocksiana and were screened against the said drug by the HPLC method. The developed method was validated for the quantification of E-and Z-guggulsterones in the gum-resin exudates of Commiphora mukul (raw form), guggulipid (ethyl acetate extract of gum-resin,) and its pharmaceutical products (finished form) that are the various components involved in the preparation of pharmaceutical products, from raw materials to finished products. The method involved a simple extraction procedure under sonication. The new method was validated as per the ICH recommended guidelines, including specificity, linearity, precision, accuracy, limit of quantitation, and robustness. The method has a validated quantitation range of 2-65 μg/mL with a precision of ±2% SD, recovery of >99.5% and correlation coefficients > 0.999 for both E-and Z-guggulsterones. The statistical analysis proves that the method is repeatable and selective for the estimation of the said drugs and can be used as a routine analytical method and applicable to the different processing components involved in the pharmaceutical preparation from Commiphora mukul resin.