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

In the pharmaceuticals industry, generally it is required to have aqueous solutions of a variety of insoluble drugs. To further increase aqueous solubility can be considered an innovation for increasing the efficacy and reducing adverse effects for certain drugs. In quantitative analysis of poorly water-soluble drugs there are requirements of various organic solvents. Hydrotropic materials can be a gateway to preclude the use of organic solvents and develop specific, precise, accurate and stability indicating methods for drug analysis.

To select a suitable hydrotropic agent for Tiopronin and optimize its concentration of hydrotrope by developing suitable HPLC method followed by method validation of an developed analytical method by HPLC as per ICH Q2(R1).

The method was developed using 0.03M Trisodium Citrate in water as the mobile phase and a Kromasil C18 (250mm*4.6mm) 5μm column, Flow rate- 1.0mL/min, and wavelength- 235 nm.

The linearity range of 10-150% met the correlation coefficient > 0.998. The %RSD for method precision was < 2.0%. The recovery range of 50-150% met 98-102%.

The analytical procedure was successfully developed and validated for specificity, Method precision, linearity, accuracy, and system suitability. Further applied for routine testing for the estimation of Tiopronin by HPLC. Additionally, the comparative greenness of the developed analytical method was superior to other literature methods.