Sami, I., Y. Rostom, H. H. Monir, and Y. S. El-Saharty, "Sustainable spectrophotometric resolution techniques for a spectrally overlapping mixture of Articaine Hydrochloride and Epinephrine Bitartrate with challenging formulation ratio", Sustainable Chemistry and Pharmacy, vol. 32, pp. 100994, 2023.
Soliman, R. M., Y. Rostom, A. M. Mahmoud, Y. M. Fayez, N. M. Mostafa, and H. H. Monir, "Novel fabricated potentiometric sensors for selective determination of carbinoxamine with different greenness evaluation perspectives", Microchemical Journal , vol. 187, pp. 108381, 2023.
Hussein, O. G., M. A. Kawy, M. R. Rezk, D. A. Ahmed, and Y. Rostom, "Novel Stability-Indicating TLC-Densitometric Method for Quantification of Antazoline and Tetryzoline; Application to Pharmaceutical Formulation", Results in Chemistry, vol. 5, pp. 100920, 2023.
Hussein, O. G., Y. Rostom, M. A. Kawy, M. R. Rezk, and D. A. Ahmed, "Spectrophotometric platform windows' exploitation for the green determination of Alcaftadine in presence of its oxidative degradation product.", Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy, vol. 297, pp. 122737, 2023. Abstract

This study presents the determination of Alcaftadine (ALF) in its oxidative degradation product presence by applying comprehensive study comparative of four different green stability indicating spectrophotometric approaches through successful exploitation of different spectrophotometric platform windows. Window I; based on absorption spectrum zero order data manipulation using the newly developed extended absorbance difference (EAD). Window II; based on derivative spectra by second order derivative (D) data manipulation. Window III; based on ratio spectra applying constant multiplication (CM) and absorptivity centering via factorized ratio difference spectrum (ACT-FSR) methods data manipulation. Finally, window IV; based on derivative of ratio spectrum by virtue of first derivative of ratio spectral (DD) method data manipulation. Calibration curves construction were over linearity range; 1.0-14.0 µg/mL for ALF. The proposed methods accuracy, precision, and linearity range were determined and validated as per ICH guidelines. Moreover, they were able to analyze ALF in raw form, dosage form and in existence of its oxidative degradation product. Statistical comparisons were done between the proposed methods and the reported one showing no significant difference concerning accuracy and precision. Furthermore, greenness profile assessment was accomplished by means of four metric tools; namely: analytical greenness (AGREE), green analytical procedure index (GAPI), analytical eco-scale, and national environmental method index (NEMI).

Hussein, O. G., D. A. Ahmed, M. A. Kawy, M. R. Rezk, A. M. Mahmoud, and Y. Rostom, "Novel solid-contact ion-selective electrode based on a polyaniline transducer layer for determination of alcaftadine in biological fluid.", RSC advances, vol. 13, issue 11, pp. 7645-7655, 2023. Abstract

Fabrication of a novel ion selective electrode for determining alcaftadine was achieved. The glassy carbon electrode (GCE) was utilized as a substrate in fabrication of an electrochemical sensor containing polyaniline (PANI) as an ion-to-electron transducer layer. A PVC polymeric matrix and nitrophenyl-octyl-ether were employed in designing the ion-sensing membrane (ISM). Potential stability was improved and minimization of electrical signal drift was achieved for inhibition of water layer formation at the electrode interface. Potential stability was achieved by inclusion of PANI between the electronic substrate and the ion-sensing membrane. The sensor's performance was evaluated following IUPAC recommendations. The sensor dynamic linear range was from 1.0 × 10 to 1.0 × 10 mol L and it had a 6.3 × 10 mol L detection limit. The selectivity and capabilities of the formed alcaftadine sensor were tested in the presence of its pharmaceutical formulation excipients as well as its degradation products. Additionally, the sensor was capable of quantifying the studied drug in a rabbit aqueous humor. Method's greenness profile was evaluated by the means of Analytical Greenness (AGREE) metric assessment tool.

Soliman, R. M., N. M. Mostafa, Y. M. Fayez, H. H. Monir, and Y. Rostom, "Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation.", Journal of AOAC International, vol. 105, issue 5, pp. 1268-1279, 2022. Abstract

BACKGROUND: Common cold and cough preparations represent a huge segment of the global pharmaceutical market. Recently, cold/cough formulations containing paracetamol (PAR) have attracted significant attention as PAR has been implemented into the supportive treatment of mild cases of COVID-19 as the first-line antipyretic. From a literature review, no method has been reported yet for simultaneous estimation of PAR, pseudoephedrine hydrochloride (PSE) and carbinoxamine maleate (CRX) in any matrix. Thus, there is an urgent need for smart and green methods that would enable quantification of the cited components in their challenging ratio.

OBJECTIVES: The aim of this work is to develop and validate the first UV spectrophotometric methods for simultaneous determination of the selected drugs taking into consideration the list of challenges including the highly overlapping features and spectral interferences in the cited mixture.

METHODS: Namely, the proposed methods are: direct spectrophotometry, dual wavelength, first derivative, derivative ratio, ratio difference, constant center coupled with spectrum subtraction, and the constant multiplication method paired with spectrum subtraction.

RESULTS: These methods were linear over the concentration range of 2.5-35, 1.5-20, and 4.5-35 μg/mL for PAR, PSE and CRX, respectively. These methods fulfill the validity parameters according to International Conference on Harmonization (ICH) guidelines. The results obtained were statistically benchmarked to the official ones where no significant difference was noticed.

CONCLUSION: The developed methods are successfully applied for concurrent quantification of the studied components in the marketed dosage form without interference from matrix excipients. The impact on the environment was assessed by five green metrics, namely a recent Analytical greenness (AGREE) metric algorithm based on the green analytical chemistry framework, Green Analytical Procedure Index (GAPI), Eco-Scale, Assessment of Green Profile (AGP), and National Environmental Methods Index (NEMI).

HIGHLIGHTS: Eco-friendly and successive spectrophotometric methods were firstly developed in this work, for the simultaneous quantification of PAR, PSE and CRX. These approaches incorporate a simple enrichment-aided technique to augment their spectrophotometric signals, facilitating the accurate quantitation of the minor component in the cited mixture.

Rostom, Y., M. Wadie, M. R. Rezk, H. M. Marzouk, and E. M. Abdel-Moety, "Fingerprinting and iso-absorptive resolution techniques for the spectrally overlapping Dutasteride and Silodosin mixture: Content uniformity testing along with greenness profile assessment.", Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy, vol. 273, pp. 121063, 2022. Abstract

The realm of spectrophotometric analysis has witnessed a remarkable progress in inventing faster and simpler resolution techniques for spectrally overlapping drug mixtures. Eco-friendly and progressive spectrophotometric methods were firstly developed in this work, for the simultaneous determination of Dutasteride (DUT) and Silodosin (SLD) in their newly-marketed dosage form. The proposed methods focused on the unique spectral features of this mixture including spectral extension of SLD over DUT spectrum as well as existence of iso-absorptive points. By such way, the methods were classified into two categories; the first one was "fingerprint resolution techniques" including constant extraction coupled with spectrum subtraction and ratio subtraction coupled with constant multiplication methods. The former represented a new modification to the classical constant extraction method where one divisor and lower steps were manipulated instead. The second category was "iso-absorptive resolution techniques", such as absorptivity centering, absorbance subtraction and amplitude modulation methods. Different solvents were investigated where ethanol was found to be the optimum one regarding drugs solubility, signal sensitivity and environmental, health & safety (EHS) score. Validity of the suggested methods was assessed as per ICH-guidelines and found to be linear over concentration ranges of 5.0-90.0 µg/mL for DUT and 5.0-120.0 µg/mL for SLD. The methods were successfully applied for quantifying the cited drugs in their combined dosage form and evaluating their content uniformity. Moreover, the insignificant statistical difference between the proposed methods and official HPLC ones encourages the utilization of such spectrophotometric methods as greener and faster candidates, especially in modest quality control laboratories. Methods' greenness profile was finally guaranteed through several assessment tools, namely; national environmental methods index (NEMI), analytical eco-scale, green analytical procedure index (GAPI) and analytical greenness (AGREE) metric.

Rostom, Y., M. hayam Lotfy, M. Öztürk, G. Tiris, N. Erk, and S. S. Saleh, "Trade-off efficacy and data processing strategy in the power of spectral resolution of co-formulated antihypertensive pharmaceuticals", Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, vol. 247, pp. 119080, 2021.
Lotfy, H. M., H. H.Monir, N. Erk, and Y. Rostom, "Novel feature extraction approach for achieving potential spectral resolution: Green analytical application on zofenopril calcium and hydrochlorothiazide in their spectrally overlapping binary mixture", Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, vol. 230, pp. 117998, 2020.
Saleh, S. S., M. hayam Lotfy, G. Tiris, N. Erk, and Y. Rostom, "Analytical tools for greenness assessment of chromatographic approaches: Application to pharmaceutical combinations of Indapamide, Perindopril and Amlodipine", Microchemical Journal, vol. 159, pp. 105557, 2020.