A Novel Eco-Friendly Approach using the Concept of Hydrotropy for Analytical Estimation of Mirtazapine by HPLC used to Treat Depression

Introduction: In the pharmaceutical field, it is often required to prepare aqueous solutions of a variety of insoluble drugs. The ability to increase aqueous solubility can be a valuable aid for increasing the efficacy and reducing adverse effects for certain drugs. Most quantitative analyses of poorly water-soluble drugs involve the use of various organic solvents. Hydrotropic solutions may be a proper choice to preclude the use of organic solvents, providing a simple, accurate, novel, safe, and precise method for drug analysis. Objective: Current research work includes development and validation of ecofriendly HPLC method using the novel concept of Hydrotropy for analytical estimation of Mirtazapine with comparative greenness with literature method. Methodology: The method was developed using 0.2% Ortho phosphoric acid in water as the mobile phase and Xterra C18 (250mm*4.6mm) 5μm column. The flow rate was set to 1.0 mL/min, and detection was done at 314 nm. Results: The linearity range of 50%-150% met the correlation coefficient > 0.998. The %RSD for method precision was < 2.0%. The recovery range of 50-150% met 98-102%. Conclusion: Hydrotropic method developed was successfully validated as per ICH Q2 (R1) with sufficient Specificity, Linearity, Accuracy and Precision. Additionally, the developed method was greener and ecofriendly compared to other literature method.