Method operable design region for robust RP-HPLC analysis of pioglitazone hydrochloride and teneligliptin hydrobromide hydrate: incorporating hybrid principles of white analytical chemistry and design of experiments

Abstract

Abstract Background A combination of pioglitazone hydrochloride with teneligliptin hydrobromide hydrate is used to treat type-2 diabetes. Several chromatographic techniques have been described in the literature for determination of each of these medications separately. But these procedures used organic solvents that could be dangerous for humans and animals, not to mention harmful to the environment. It is vital to substitute or reduce the use of these neurotoxic and teratogenic solvents in the chromatographic analysis of these anti-diabetic medications to ensure the safety of life and safeguard the environment. The chromatographic technique used for sample analysis should have characteristics like robustness, eco-friendliness, cost-effectiveness, and user-friendliness following the recently developed idea of white analytical chemistry. Teneligliptin and pioglitazone have not yet been simultaneously estimated using a chromatographic method that has been documented in the literature. Methods A white analytical chemistry-assisted RP-HPLC method has been developed to fill this gap, using economical and eco-friendly solvents. The design of the experiment approach was used during the development of the RP-HPLC method to reduce organic waste and guarantee that the procedure complied with all applicable regulations. Response surface models were built using the full factorial design approach, and the analytical design space was investigated. This method allowed for the identification of an optimal chromatographic condition within the method's operational design region, allowing reliable RP-HPLC analysis of pioglitazone and teneligliptin. Results The developed RP-HPLC technique underwent validation and was used effectively to assess these drugs in their fixed-dose combinations. Assessments were made of the suggested and published RP-HPLC techniques' validation status, process greenness, cost, and analysis time. For a thorough examination, this review included white analytical chemistry-based RGB models and different green analytical chemistry-based tools. Conclusion In allowing the simultaneous estimate of teneligliptin and pioglitazone, the devised approach demonstrated robustness, eco-friendliness, and cost-effectiveness.

Keywords

• Teneligliptin hydrobromide hydrate
• Pioglitazone hydrochloride
• White analytical chemistry
• Design of experiments
• Analytical quality by design