Publication

Abstract : This study describes the establishment and bioanalytical validation of a single, sensitive, and affirmative High-Performance Liquid Chromatography (HPLC) procedure to determine the concomitant quantification of essential phytoconstituents, gallic acid, curcumin, and piperine in a standardised Ayurvedic polyherbal formulation. Due to the complicated nature of herbal mixtures, the quality, efficacy, and safety of products can only be guaranteed by effective analytical methods. A C18 reverse-phase column (250 × 4.6 mm, 5 µm) with a gradient elution of acetonitrile and 0.1% formic acid in water as the mobile phase, and UV determination at 280 nm was used to attain the chromatographic separation. The technique was confirmed as per the ICH Q2(R2) requirements on linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. All the analytes had linear calibration curves in the years 0.1 to 10 µg/mL with correlation coefficients (r2) of more than 0.999. Recovery was found to be between 98% and 102% with relative standard deviation (RSD) being less than 2%. The LOD and LOQ readings were in the nanogram scale, indicating the method to be highly sensitive. The data is valid as the method was used to measure phytoconstituents in an Ayurvedic product commercial formulation, confirming the suitability of the method in quality control and standardisation. The study offers a valid and reliable method of analysis that can be reproduced and applied to close the gap between Ayurvedic medicine and the bioanalytical validation to maintain a consistent therapeutic standard and regulation.