NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF LECITHIN AND SILYMARIN

Objective: A simple, rapid, accurate, precise and reproducible validated RP- HPLC method was developed for the determination of Lecithin and Silymarin in bulk and tablet dosage forms. Methods: A simple double beam UV spectrophotometric method has been developed and validated with different parameters such as linearity, precision, repeatability, the limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. Results: The quantification was carried out using Symmetry PremsilC­₁₈ (250mm x 4.6mm, 5µm) column run in an isocratic way using mobile phase comprising of acetonitrile: water (0.1% OPA with PH 3) 70:30 v/v and a detection wavelength of 236 nm and injection volume of 20µL, with a flow rate of 1ml/min. The retention times of Lecithin and Silymarin were found to be 6.58 min and 3.616min. The method was validated in terms of linearity, precision, accuracy, LOD, LOQ, and robustness in accordance with ICH guidelines. The assay of the proposed method was found to be 99-101%. The recovery studies were also carried out, and the mean % recovery was found to be 99-101%. The % RSD from reproducibility was found to be <2%. Conclusion: The proposed method was statistically evaluated and can be applied for routine quality control analysis of Lecithin and Silymarin in bulk and in the tablet dosage form.