An approach to enhanced stability: Formulation and characterization of derived lycopene based topical emulgel.

Focus of the study was to design a novel and cost effective extraction technique for the lycopene from L. fruit and to develop and characterize a stable emulgel formulation containing lycopene as an active ingredient as well as to design an analytical method to determine lycopene concentration in emulgel. Emulgel formulation was prepared and evaluated for its stability at different storage conditions, 8 °C, 25 °C, 40 °C, 40 °C + 75% relative humidity (RH) and 50 °C, for 6 months. Results were statistically analyzed using two way ANOVA, Post-Hoc test and paired sample -test at 5% significance level. Designed extraction technique presented comparable yield, 154.83 mg/Kg of tomato fruit, with all recoveries in the range of 145-156 mg/Kg of tomato. "P-values" calculated for different levels of stability parameters were <0.05, except at 50 °C and time points of 60th day and later. Analytical method designed was having linear range of lycopene 1-10 µg/mL with limit of detection 0.11 µg/mL and limit of quantification 0.34 µg/mL. All inter-day and intra-day recoveries were in the range of 94-105% while in all measurements RSD % was ≤5.36. It can be concluded that the extraction technique was cost effective with comparable results and analytical method was simple, robust, specific and sensitive enough to be used for lycopene concentration determination in emulgel formulation. Furthermore, designed formulation was stable even at high temperature of 40 °C and RH 75%.