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

Document Type : Original Article

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pharmaceutical analytical chemistry, faculty of pharmacy, Mist International University, cairo, Egypt

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.

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