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Two-wavelength manipulation stability-indicating spectrophotometric methods for determination of meropenem and ertapenem: greenness consolidation and pharmaceutical product application

Ahmed S. Fayed, Rania M. Youssif, Nahla N. Salama, Hassan A. Hendawy, and Eman S. Elzanfaly

Cairo University, Cairo, Egypt

 

E-mail: fayedaeg@yahoo.com

Abstract: Green assessed, UV-spectrophotometric methods were developed and validated for estimation of meropenem (MP) and ertapenem (EP), categorized to be non-classical β-lactam antibiotics, in the presence of their corresponding oxidative and hydrolytic degradants. The methods were successful to be used as stability-indicating ones and be applied for determination of the cited compounds in drug product and in pharmaceutical formulations. Three different spectrophotometric methods concerning two wavelengths manipulation for drug-degradant mixture resolution were adopted, namely; dual and induced dual wavelength, ratio difference, and advanced amplitude centering for partially overlapping spectra. Testing of the methods selectivity was achieved by successful analysis of synthetic mixtures of the studied drugs with different degradants. Validation was performed according to the USP guidelines. Application to pharmaceutical formulations and standard addition technique proved the methods’ analytical performance. Statistical comparison of the obtained results with those of the official or reported HPLC methods was performed using student t test, F test, and one-way ANOVA, where no significant differences with respect to accuracy and precision were observed. The greenness evaluation of the developed methods was assessed by applying two metrics to ensure environmental and personnel safety. No prior separation or long preparation steps were required for the proposed methods. The developed methods were specific, cost effective, and environmentally safe, less time-consuming methods for the quantitative determination of MP and EP in quality control laboratories with acceptable ultra-micro-linearity ranges and a promising wider applicability.

Keywords: Meropenem ; Ertapenem ; Stability-indicating ; Dual and induced dual wavelength ; Ratio difference ; Advanced amplitude centering 

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-019-00824-8

 

Chemical Papers 73 (11) 2723–2736 (2019)

Wednesday, April 24, 2024

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