Development of simple stability indicating RP-HPLC method to estimate ferulic acid in niosomes and marketed products using quality by design approach

Ferulic acid found in Feru-guard which is obtained from rice bran. This compound occurs in a wide range of plant sources including pineapple, various grasses, rice, leaves, beans, coffee beans, oats, grains, vegetables, flowers, fruits, peanuts and nuts. Particularly, it received a lot of attention due to its potential therapeutic uses in different pathologies, including metabolic, viral infections, cancer, cardiovascular, skin disorders, diabetes, hepatotoxicity and neurodegeneration. The article describes the methodical development of a simple, fast, highly sensitive, durable, efficient and economically viable reversed-phase high-performance liquid chromatography (RP-HPLC) technology for measuring ferulic acid. The analysis was Performed using the Central composite design (CCD), which offers the advantage of employing a reduced number of design points and experimental runs. Employing the response surface methodology via central composite design (CCD), the study thoroughly assessed the influence of these factors. The proposed analytical method underwent comprehensive validation, ensuring its reliability as per the guidelines outlined in ICH Q2A and ICH Q2B.The preferred method employed a mobile phase consisting of Methanol and OPA buffer (50:50 % v/v, pH maintain to 4.2 with 0.1 % orthophosphoric acid), operating at a flow rate of 1 mL min-1,with a Chemsil ODS column, the wavelength of detection was set at 320 nm. According to the novel analytical method, Ferulic Acid exhibited a peak retention time of approximately 6.13 min. The method demonstrated linearity range of 0.5-16 mu g/ml. The developed approach proved to be robust, precise and accurate, with a recovery rate of 98 %. It achieved % relative standard deviation (RSD) of below 2 %,The current stable RP-HPLC method was effectively employed for the characterization of niosomes loaded with Ferulic Acid. Furthermore, degradation studies were conducted under various conditions to elucidate the degradation pathways and resultant products.