Greenness Assessment of Spectrofluorometric Method for Quantification of Ertugliflozin: Application to Dosage Form and Human Urine.

Abstract

The proposed work describes an ecofriendly, cost-effective, and sensitive spectrofluorometric method for the determination of ertugliflozin (ERT) in bulk material, pharmaceutical dosage form, and human urine. The method was developed by measuring the native fluorescence of the cited drug at λem= 334 nm after excitation at λex = 270 nm using water as a solvent. Different variables affecting the native fluorescence nature of ERT were successfully studied to obtain the optimum conditions of the proposed method. The assay was validated according to ICH guidelines for analytical and bioanalytical method validation and satisfactory results were obtained; percentage recoveries ranged between 99.47% and 101.36% and between 99.19 % and 101.90% upon analysis of ERT in dosage form and human urine respectively. No significant matrix effect was observed while measuring ERT in pharmaceutical dosage form or in human urine. The proposed method is considered the first spectrofluorometric method for quantification of ertugliflozin in dosage forms and human urine and can be applied to biological samples obtained from a pharmacokinetic study of ERT. Moreover, the method greenness was investigated by applying two different techniques and a comparative study was performed between the proposed method and other reported methods.

Comparing the Greenness and Validation Metrics of Traditional and Eco-Friendly Stability-Indicating HPTLC Methods for Ertugliflozin Determination

“…Using LC-MS/MS techniques, ERZ has also been quantified in rat plasma samples in conjunction with sitagliptin or metformin. , The determination of ERZ in pure forms and pharmaceutical preparations, either in conjunction with sitagliptin or alone, has also been performed utilizing various ultraperformance LC-MS/MS (UPLC-MS/MS) techniques. − Using a UPLC-MS/MS approach, ERZ and sitagliptin have also been measured simultaneously in rat plasma samples . A green spectrofluorometric method was also used to determine ERZ in dosage forms and human urine samples . To the best of our knowledge, no reports of ERZ measurement in commercial products have been made using traditional or eco-friendly HPTLC techniques.…”

“… 25 A green spectrofluorometric method was also used to determine ERZ in dosage forms and human urine samples. 26 To the best of our knowledge, no reports of ERZ measurement in commercial products have been made using traditional or eco-friendly HPTLC techniques. HPTLC analytical procedures present numerous benefits such as low solvent usage/waste, nondestructive mode of detection, ease of use, minimal pretreatment, efficiency, simultaneous detection of multiple samples, nontoxic, and greenness features over conventional liquid chromatography methods (HPLC, LC-MS, and UPLC methods) for the analysis of pharmaceutical compounds.…”