Stability indicating HPTLC method for active principle psoralen and its application to accelerated stability testing of marketed formulation

Abstract

Psoralen is a phytoconstituent found in the plant. Psoralea corylifolia also known as Bawchi/Bakuchi in India. A stability indicating HPTLC method for estimation of psoralen has been developed. The effects of accelerated conditions on the psoralen content from marketed formulation (seed powder) was studied. The powder of dried seeds and standard psoralen were applied to silica gel 60 F254 aluminium-supported precoated TLC plates using optimised mobile phase containing toluene: ethyl acetate 9: 1 (v/v). Densitometric scanning was conducted at λmax= 246 nm. A compact peak for psoralen (Rf= 0.62±0.03) was observed with linearity ranging from 40 ng-200 ng/band with good correlation coefficient of r2= 0.991. The standard marker was subjected to degradation studies as per ICH Q1A (R2) guidelines and found susceptible to degradation in all conditions like hydrolysis, photolytic, oxidation and thermal. The marketed formulation (seed powder) was exposed to accelerated conditions for 3 months. The method was found to be reproducible, selective and reliable for estimation of stability of standard psoralen in marketed formulations.