HPTLC method for guggulsterone; I. Quantitative determination of E- and Z-guggulsterone in herbal extract and pharmaceutical dosage form.

摘要

A sensitive, selective, precise and robust high-performance thin-layer chromatographic method of analysis of E and Z stereoisomers of guggulsterone (the hypolipidemic agent in the gum-resin exudates of Commiphora mukul) both as a bulk drug and in formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene-acetone (9:1, v/v). Densitometric analysis of guggulsterone was carried out in the absorbance mode at 250nm. This system was found to give compact spots for E- and Z-guggulsterone (R(f) value of [Formula: see text] and [Formula: see text], respectively) following double development of chromatoplates with the same mobile phase. The linear regression analysis data for the calibration plots for E- and Z-guggulsterone showed good linear relationship with [Formula: see text] and 0.9975 +/- 0.068, respectively, in the concentration range of 100-6000ng/spot. The mean value of slope and intercept were [Formula: see text] and [Formula: see text], [Formula: see text] and [Formula: see text], respectively, for E- and Z-guggulsterone. The method was validated for precision, robustness and recovery. The limit of detection and quantitation were 12, 10 and 24, 20ng/spot, respectively, for E- and Z-guggulsterone. Statistical analysis proves that the method is repeatable and selective for the estimation of the said drug. Since the proposed mobile phase effectively resolves the E- and Z-isomers of guggulsterone, this HPTLC method can be applied for identification and quantitation of these isomers in herbal extracts and pharmaceutical dosage form.