Document Type

Research Project

Publication Date

Summer 9-3-2023


Single tablet regimens (STRs) for hypertension suppression improve patient satisfaction, quality of life, medication and adherence compared to multi-tablet regimens (MTRs). Development of simple cost effective and at the same time green an ecofriendly method for analysis and resolution of multicomponent and complex mixtures is an increasingly important issue in the field of pharmaceutical industry in general and analytical chemistry in specific. Thus, the presented research deals with two main goals, the first one is concerned with developing and applying a fully validated resolution plan using numerical data of signals on manipulated spectra for successive extraction of parent spectra of drugs in single-tablet Regimens (STRs) used in antihypertensive treatment. The STRs contains three drugs with deconvoluted spectra, Atenolol (ATL), Amiloride (AMD) and Chlortalidone (CLN). The resolution plan encompasses two simple and affordable spectrophotometric methods employing resolving spectra either normalized spectrum (NS) or factorized spectrum (FS) which acts as a master key for unlocking the overlapped spectra of ternary mixture with no need for any preliminary physical separation, sample pretreatment or pH adjustment. These two main methods namely, dual amplitude difference (DAD) and derivative ratio transformation (DDT). The presented approaches required a simple spectrophotometer with its built-in program using primitive mathematical operations to restore the parent spectrum for individually drug cited in the mixture understudy. The proposed methods validity was checked and evaluated through the ICH guidelines and displayed linearity within concentration range 4.0-40.0μg/mL for ATL, 3.0-20.0μg/mL for both AMD and CLN. While the specificity evaluation was performed via assaying the three drugs accurately and precisely in their synthetic mixtures and in their STRs. Generally, these methods could be recruited for the fast and effective analysis and determination of the purity index for AMD, CLN and ATL in bulk materials and available market formulation, Teklo ® tablets. The second main goal of the research was the evaluation of the methods greenness and whiteness where the applied UV-methods and the reported HPLC one had significantly different greenness scores when compared using three metrics: the Green Certificate Classification (GCC), the Complex Green Analytical Procedure Index (Complex-GAPI), and the Analytical Greenness metric approach (AGREE). Also, the whiteness scores, which reflected the degree of the achieved sustainability for the HPLC reported technique and the produced UV ones were done by using the ideologies of the white analytical chemistry (WAC) tool. All the differences between the four aforementioned metrics are discussed in this study.


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