"Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantification of Embelin in Pure Form and Transethosomal Formulations"

This research outlines the development and validation of a reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative analysis of embelin, a biologically active hydroxyquinone predominantly sourced from Embelia ribes. Recognized for its diverse pharmacological properties including antioxidant, antidiabetic, anti-inflammatory, and anticancer activities embelin was analyzed using a Phenomenex Luna C18(2) column with a mobile phase composed of acetonitrile and 0.1% orthophosphoric acid (90:10 v/v), at a flow rate of 1.0 mL/min, with detection at 291 nm. The method was validated according to ICH Q2(R1) guidelines, assessing key parameters such as linearity, accuracy, precision, robustness, and the limits of detection (LOD) and quantification (LOQ). The calibration curve displayed strong linearity (R² = 0.9988) within the concentration range of 2–10 μg/mL. Sensitivity was confirmed with an LOD of 0.111 μg/mL and an LOQ of 0.555 μg/mL. Stability-indicating capability was demonstrated through forced degradation studies under various stress conditions, including acidic, basic, thermal, oxidative, and photolytic environments. The validated method was effectively applied to determine embelin content in transethosomal formulations, confirming its suitability for routine pharmaceutical quality control and analytical applications