Validation of a Rapid and Sensitive Reversed-Phase Liquid Chromatography Method and Force Degradation Study of Synthesized (E)-۳-(۲,۴,۶-tri-Methoxyphenyl)-۱-phenylpro-۲ ene-۱-one

A stability-indicating RP-HPLC method was developed and validated for the determination of  the estimation of newly synthesized (E)-۳-(۲,۴,۶-tri-methoxyphenyl)-۱-phenylpro-۲ ene-۱-one in API form by using C۱۸ column Phenomenix (۲۵۰ mm x۴.۶ mm,۵µm), with a mobile phase consisting of a acetonitrile and  methanol (۴۰:۶۰ v/v) with flow rate of ۰.۷ mL/min. The detection was carried out at ۳۷۰ nm and retention time (Rt) of (E)-۳-(۲, ۴, ۶- tri-methoxyphenyl)-۱-phenylpro-۲ ene-۱-one was found to be ۲.۵۵ min. Linearity was observed from the concentration range of ۱۰-۵۰µg/mL (n=۵), (coefficient of determination R۲ was ۰.۹۹۷) with the equation of y= ۰.۴۹۵x + ۰.۱۱۱. The method was repeatable with a relative standard deviation (RSD) of ۰.۱۶ to ۱.۹۸ %. The newly developed method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. (E)-۳-(۲,۴,۶-tri-methoxyphenyl)-۱-phenylpro-۲ ene-۱-one was subjected to different stress conditions as per ICH guidelines like acidic alkaline, oxidative, thermal and the results showed that it was more sensitive towards oxidative.

Keywords:

RP-HPLC , (E)-۳-(۲ , ۴ , ۶-tri-methoxyphenyl)-۱-phenylpro-۲ene-۱-one , زharacterization