Validation of a Rapid and Sensitive Reversed-Phase Liquid Chromatography Method and Force Degradation Study of Synthesized (E)-3-(2,4,6-tri-Methoxyphenyl)-1-phenylpro-2 ene-1-one

A stability-indicating RP-HPLC method was developed and validated for the determination of the estimation of newly synthesized (E)-3-(2,4,6-tri-methoxyphenyl)-1-phenylpro-2 ene-l-one in API form by using C18 column Phenomenix (250 mm x4.6 mm,5 mu m), with a mobile phase consisting of a acetonitrile and methanol (40:60 v/v) with flow rate of 0.7 mL/min. The detection was carried out at 370 nm and retention time (Rt) of (E)-3-(2, 4, 6-tri-methoxyphenyl)-1-phenylpro-2 ene-1-one was found to be 2.55 min. Linearity was observed from the concentration range of 10-50 mu g/mL (n=5), (coefficient of determination R-2 was 0.997) with the equation of y= 0.495x + 0.111. The method was repeatable with a relative standard deviation (RSD) of 0.16 to 1.98 %. The newly developed method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. (E)-3-(2,4,6-tri-methoxyphenyl)-1-phenylpro-2 ene-1-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. [GRAPHICS] .

Automated summary

A stability-indicating RP-HPLC method was developed and validated for the determination of a newly synthesized compound in API form. The method showed good linearity and precision, and was validated according to ICH guidelines.