Failure Mode Effects Analysis and Design of Experiments to Sensitive and Sustainable Microwave-Aided Spectrofluorophotometric Estimation of Teneligliptin and Method's Chlor-Tox Scale and Blue Applicability Grade Index Assessment

Abstract

Teneligliptin hydrobromide hydrate is efficiently controls blood sugar levels while minimizing the risk of hypoglycemia. Determination of teneligliptin in commercial formulations and biological-fluids has been documented in literature using a plethora of chromatographic, spectrophotometric, and hyphenated methods and they required toxic organic solvents. But, there was no published spectrofluorophotometric technique for teneligliptin estimation. Hence, microwave-aided spectrofluorophotometric method was developed to estimate teneligliptin with using green solvents and 7-chloro-4-nitrobenzoxadiazole as a fluorescent probe. An integrated approach of white analytical chemistry and analytical quality by design was used to estimate teneligliptin in a robust, accurate, and precise manner. The failure mode effect analysis was used to identify the critical analytical method parameters and response variables. The design of experiments was used to carry forward the important analytical method parameters and response variables for response surface modeling. The proposed spectrofluorophotometric method was applied to evaluate commercially available formulations and investigate the pharmacokinetics of teneligliptin–loaded nano-carriers that was developed in-house. The fluorescent product that was derivatized using microwaves was separated and studied using mass spectrometry. After greenness and whiteness profile assessment, researchers discovered that the suggested approach to teneligliptin estimate was eco-friendly, precise, robust, rapid, economical, and easy to apply.