首页|Different approaches for the assessment of greenness of spectrophotometric methodologies utilized for resolving the spectral overlap of newly approved binary hypoglycemic pharmaceutical mixture
Different approaches for the assessment of greenness of spectrophotometric methodologies utilized for resolving the spectral overlap of newly approved binary hypoglycemic pharmaceutical mixture
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NSTL
Elsevier
Simultaneous measurement of saxagliptin hydrochloride (SAG) and dapagliflozin propanediol monohy-drate (DAG) in bulk powder, laboratory-prepared mixtures, and pharmaceutical dosage form were applied by utilizing three precise and sensitive spectrophotometric techniques which were developed and validated. The first method was the induced dual-wavelength approach (IDW), which relied primar-ily on the use of alternative equality factors (F) to abolish the effect of DAG when determining SAG and vice versa. The ratio difference method (RDM) was the second method, which used 25 mu g/ml of DAG and 20 mu g/ml of SAG as divisors to determine the amplitude difference on the ratio spectrum of SAG and DAG, respectively. SAG was determined at lambda(max) 221 nm after plateau subtraction followed by multiplication by the divisor of DAG 25 lg/ml using the third method, ratio subtraction coupled with extended ratio sub-traction method (RSER). Subsequently, using an extension ratio subtraction of the spectra, DAG was determined at lambda(max) 225 nm was determined. The developed methods were effectively used to estimate SAG and DAG in laboratory-prepared mixtures and pharmaceutical dosage forms, with satisfactory recov-eries. The methodologies were assessed for their environmental friendliness using the analytical eco-scale, analytical GREEnness calculator, and green analytical procedure index (GAPI). These methodologies were validated following the International Conference on Harmonisation (ICH) requirements. A statistical comparison of the obtained findings to those of the published method revealed no significant differences in precision and accuracy. Because of their high precision and cost-effectiveness, the developed methods can be used in quality control laboratories to determine the binary mixture. (c) 2022 Elsevier B.V. All rights reserved.
DapagliflozinEco-friendlyExtended ratio subtractionInduced wavelengthRatio differenceSaxagliptinUV spectrophotometryValidationCOMBINATION THERAPYHPLC METHODSAXAGLIPTINDAPAGLIFLOZINMANAGEMENTVALIDATIONPLASMAASSAYBULK
Fawzy, Michael Gamal、Hassan, Wafaa Elsayed、Mostafa, Alaa Ahmed、Sayed, Rania Adel
NSTL
Elsevier
