In-Vitro Dissolution Study of Solid Dispersion Adsorbate of Nateglinide by Eco-Friendly Liquid Chromatography-Tandem Mass Spectrometric Method through Harmonized Approach of White Analytical Chemistry and Analytical Quality by Design

Abstract

Purpose: Nateglinide, a member of the meglitinide class, is used as an oral antihyperglycemic agent to treat non-insulin-dependent diabetes mellitus. It falls under the BCS class II category and has a low solubility (0.00848 mg/mL), posing challenges in its formulation. To overcome this, a solid dispersion adsorbate of nateglinide was prepared using the fusion method applying 32 factorial experimental design. There are several analytical techniques for quantifying nateglinide in pharmaceutical formulations and biological fluids, but many depend on toxic organic solvents in their mobile phases, which can be harmful to the environment. Methods: To address this issue, a green liquid chromatographic-tandem mass spectrometric method was developed. This method, used for assessing the in-vitro dissolution study of the solid dispersion adsorbate of nateglinide, employs low toxic organic solvents. The method development adhered to the principles of analytical quality by design to minimize the generation of organic waste. Results: The chromatographic analysis was conducted using a C8 column (50 mm × 2.1 mm, 1.7 μm) with 20.0 mmol/L ammonium acetate and ethanol (75:25, v/v) as the mobile phase. Conclusions: In conclusion, this analytical approach not only ensures accurate analysis of nateglinide but also promotes sustainability by reducing environmental impact.