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Article ; Online: Development and validation of analytical methods for selective determination of albuterol and budesonide in Airsupra inhalation aerosol using spectrophotometry.

Almalki, Atiah H / Ramzy, Sherif / Almrasy, Ahmed A

2023 Volume 13, Issue 1, Page(s) 16587

Abstract: Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively ...

Abstract	Airsupra inhalation aerosol is a recently approved FDA medication that combines albuterol and budesonide for treating or preventing bronchoconstriction and lowering the risk of relapses in asthma patients who are 18 years of age and older. To selectively determine albuterol and budesonide in both pure and pharmaceutical dosage forms, two analytical methods were developed: the zero-order absorption method and the dual-wavelength method. Even though the two drugs absorption spectra overlapped, the distinctive peak of budesonide at the zero absorbance point of albuterol, 245 nm, allowed for direct detection of budesonide in the combination using the zero-order absorption method. The mathematical dual-wavelength method, on the other hand, allowed for the measurement of both albuterol and budesonide by choosing two wavelengths for each drug in such a way that the absorbance difference for the second drug was zero. Budesonide exhibited comparable absorbance values at wavelengths 227 and 261.40 nm; hence, these two wavelengths were utilized to identify albuterol; similarly, 221.40 and 231.20 nm were chosen to determine budesonide in their binary mixes. The methods were validated according to the ICH guideline for validation of analytical procedures Q2(R1) and demonstrated excellent linearity, sensitivity, accuracy, precision, and selectivity for determining both drugs in synthetic mixed solutions and pharmaceutical formulations. The availability of these analytical methods would be valuable for the pharmaceutical industry and regulatory authorities for quality control and assessment of pharmaceutical formulations containing albuterol and budesonide.
MeSH term(s)	Humans ; Adolescent ; Adult ; Albuterol ; Budesonide ; Respiratory Aerosols and Droplets ; Administration, Inhalation ; Spectrophotometry/methods ; Pharmaceutical Preparations ; Bronchodilator Agents
Chemical Substances	Albuterol (QF8SVZ843E) ; Budesonide (51333-22-3) ; Pharmaceutical Preparations ; Bronchodilator Agents
Language	English
Publishing date	2023-10-03
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-42766-y
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Article ; Online: Higher sensitive selective spectrofluorometric determination of ritonavir in the presence of nirmatrelvir: application to new FDA approved co-packaged COVID-19 pharmaceutical dosage and spiked human plasma.

Imam, Mohamed S / Abdelazim, Ahmed H / Ramzy, Sherif / Almrasy, Ahmed A / Gamal, Mohammed / Batubara, Afnan S

BMC chemistry

2023 Volume 17, Issue 1, Page(s) 120

Abstract: Background: Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive ... ...

Abstract	Background: Ritonavir was recently combined with nirmatrelvir in a new approved co-packaged medication form for the treatment of COVID-19. Quantitative analysis based on fluorescence spectroscopy measurement was extensively used for sensitive determination of compounds exhibited unique fluorescence features. Objective: The main objective of this work was to develop higher sensitive cost effective spectrofluorometric method for selective determination of ritonavir in the presence of nirmatrelvir in pure form, pharmaceutical tablet as well as in spiked human plasma. Methods: Ritonavir was found to exhibit unique native emission fluorescence at 404 nm when excited at 326 nm. On the other hand, nirmatrelvir had no emission bands when excited at 326 nm. This feature allowed selective determination of ritonavir without any interference from nirmatrelvir. The variables affecting fluorescence intensity of ritonavir were optimized in terms of sensitivity parameters and principles of green analytical chemistry. Ethanol was used a green solvent which provided efficient fluorescence intensity of the cited drug. Results: The method was validated in accordance with the ICH Q2 (R1) standards in terms of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and specificity. The described method was successfully applied for ritonavir assay over the concentration range of 2.0-20.0 ng/mL. Conclusion: Ritonavir determination in the spiked human plasma was successfully done with satisfactory accepted results.
Language	English
Publishing date	2023-09-21
Publishing country	Switzerland
Document type	Journal Article
ISSN	2661-801X
ISSN (online)	2661-801X
DOI	10.1186/s13065-023-01030-0
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Article ; Online: Quantitative analysis of two COVID-19 antiviral agents, favipiravir and remdesivir, in spiked human plasma using spectrophotometric methods; greenness evaluation.

Batubara, Afnan S / Abdelazim, Ahmed H / Almrasy, Ahmed A / Gamal, Mohammed / Ramzy, Sherif

BMC chemistry

2023 Volume 17, Issue 1, Page(s) 58

Abstract: Favipiravir and remdesivir have been included in the COVID-19 treatment guidelines panel of several countries. The main objective of the current work is to develop the first validated green spectrophotometric methods for the determination of favipiravir ... ...

Abstract	Favipiravir and remdesivir have been included in the COVID-19 treatment guidelines panel of several countries. The main objective of the current work is to develop the first validated green spectrophotometric methods for the determination of favipiravir and remdesivir in spiked human plasma. The UV absorption spectra of favipiravir and remdesivir have shown some overlap, making simultaneous determination difficult. Due to the considerable overlap, two ratio spectra manipulating spectrophotometric methods, namely, ratio difference and the first derivative of ratio spectra, enabled the determination of favipiravir and remdesivir in their pure forms and spiked plasma. The ratio spectra of favipiravir and remdesivir were derived by dividing the spectra of each drug by the suitable spectrum of another drug as a divisor to get the ratio spectra. Favipiravir was determined by calculating the difference between 222 and 256 nm of the derived ratio spectra, while calculating the difference between 247 and 271 nm of the derived ratio spectra enabled the determination of remdesivir. Moreover, the ratio spectra of every drug were transformed to the first order derivative using ∆λ = 4 and a scaling factor of 100. The first-order derivative amplitude values at 228 and 251.20 nm enabled the determination of favipiravir and remdesivir, respectively. Regarding the pharmacokinetic profile of favipiravir (C
Language	English
Publishing date	2023-06-16
Publishing country	Switzerland
Document type	Journal Article
ISSN	2661-801X
ISSN (online)	2661-801X
DOI	10.1186/s13065-023-00967-6
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Article ; Online: Adjusted green HPLC determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged pharmaceutical dosage using supported computational calculations.

Imam, Mohamed S / Batubara, Afnan S / Gamal, Mohammed / Abdelazim, Ahmed H / Almrasy, Ahmed A / Ramzy, Sherif

Scientific reports

2023 Volume 13, Issue 1, Page(s) 137

Abstract: The greening of analytical methods has gained interest in the quantitative analysis field to reduce environmental impact and improve safety health conditions for analysts. Nirmatrelvir plus ritonavir is a new FDA approved co-packaged medication developed ...

Abstract	The greening of analytical methods has gained interest in the quantitative analysis field to reduce environmental impact and improve safety health conditions for analysts. Nirmatrelvir plus ritonavir is a new FDA approved co-packaged medication developed for the treatment of COVID-19. The aim of this research was to develop green fitted HPLC method using pre experimental computational testing of different stationary phases as well as selecting mobile phase regarding to green analytical chemistry principles. Computational study was designed to test the physical interaction between nirmatrelvir and ritonavir and different columns (C8, C18, Cyano column). The study showed that the C18 column was better for simultaneous HPLC analysis of the cited drugs. Regarding to green point of view, mobile phase consisted of ethanol: water (80:20, v/v) provided an efficient chromatographic separation of nirmatrelvir and ritonavir within a short analytical run time, reasonable resolution and excellent sensitivity. Isocratic elution was performed on a selected C18 column and a green adjusted mobile phase at flow rate of 1 mL/min and UV detection at 215 nm. The chromatographic system allowed complete baseline separation with retention times of 4.9 min for nirmatrelvir and 6.8 min for ritonavir. The method succeeded to determine nirmatrelvir and ritonavir over the concentration range of 1.0-20.0 μg/mL in the pure form and in pharmaceutical dosage form. Greenness profiles of the applied HPLC method was assessed using analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The results revealed adherence of the described method to the green analytical chemistry principles. The authors hope to provide a promising challenge for achieving green goals through integrating computational tools and applying them with green assessment metrics.
MeSH term(s)	Humans ; Chromatography, High Pressure Liquid/methods ; Ritonavir ; COVID-19 ; COVID-19 Drug Treatment ; Lactams ; Pharmaceutical Preparations
Chemical Substances	Ritonavir (O3J8G9O825) ; Lactams ; Pharmaceutical Preparations
Language	English
Publishing date	2023-01-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-26944-y
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Article ; Online: Green fitted second derivative synchronous spectrofluorometric method for simultaneous determination of remdesivir and apixaban at Nano gram scale in the spiked human plasma.

Batubara, Afnan S / Abdelazim, Ahmed H / Gamal, Mohammed / Almrasy, Ahmed A / Ramzy, Sherif

Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

2022 Volume 290, Page(s) 122265

Abstract: Remdesivir and apixaban have been included in the treatment guidelines of several countries for severe COVID-19 infections. To date, no analytical method has been developed for the determination of remdesivir and apixaban in plasma matrix. The main ... ...

Abstract	Remdesivir and apixaban have been included in the treatment guidelines of several countries for severe COVID-19 infections. To date, no analytical method has been developed for the determination of remdesivir and apixaban in plasma matrix. The main objective of this work was to develop a highly sensitive, green-adapted spectrofluorometric method for the determination of remdesivir and apixaban at the Nanoscale. Remdesivir and apixaban showed overlapping fluorescence emission spectra at 403 nm and 456 nm when excited at 246 nm and 285 nm, respectively. This overlap was resolved in two steps. The first step was synchronous fluorescence scanning of remdesivir and apixaban, and the second step was manipulation of the second-order derivative for the obtained spectra. These steps allowed complete resolution of the overlapping fluorescence spectra and selective determination of remdesivir and apixaban at 410 and 469 nm, respectively. The variables affecting the synchronous scanning of the aforementioned drugs were optimized in terms of sensitivity parameters and principles of green analytical chemistry. The described method allowed sensitive determination of remdesivir and apixaban over the concentration range of 5-200 ng/mL and 50-3000 ng/mL, respectively. The described method was validated and successfully applied for the simultaneous determination of the mentioned drugs in pure form and in spiked human plasma.
MeSH term(s)	Humans ; COVID-19 ; COVID-19 Drug Treatment ; Spectrometry, Fluorescence/methods
Chemical Substances	apixaban (3Z9Y7UWC1J) ; remdesivir (3QKI37EEHE)
Language	English
Publishing date	2022-12-20
Publishing country	England
Document type	Journal Article
ZDB-ID	210413-1
ISSN	1873-3557 ; 0370-8322 ; 0584-8539 ; 1386-1425
ISSN (online)	1873-3557
ISSN	0370-8322 ; 0584-8539 ; 1386-1425
DOI	10.1016/j.saa.2022.122265
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Article ; Online: Green adherent spectrophotometric determination of molnupiravir based on computational calculations; application to a recently FDA-approved pharmaceutical dosage form.

Abdelazim, Ahmed H / Abourehab, Mohammed A S / Abd Elhalim, Lobna M / Almrasy, Ahmed A / Ramzy, Sherif

Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

2022 Volume 285, Page(s) 121911

Abstract: Molnupiravir is an oral antiviral drug developed to provide significant benefit in reducing hospitalizations or deaths in mild COVID-19. Integrated green computational spectrophotometric method was developed for the determination of molnupiravir. ... ...

Abstract	Molnupiravir is an oral antiviral drug developed to provide significant benefit in reducing hospitalizations or deaths in mild COVID-19. Integrated green computational spectrophotometric method was developed for the determination of molnupiravir. Theoretical calculations were performed to predict the best coupling agent for efficient diazo coupling of molnupiravir. The binding energy between molnupiravir and various phenolic coupling agents, α-naphthol, β-naphthol, 8-hydroxyquinoline, resorcinol, and phloroglucinol, was measured using Gaussian 03 software based on the density functional theory method and the basis set B3LYP/6-31G(d). The results showed that the interaction between molnupiravir and 8-hydroxyquinoline was higher than that of other phenolic coupling agents. The method described was based on the formation of a red colored chromogen by the diazo coupling of molnupiravir with sodium nitrite in acidic medium to form a diazonium ion coupled with 8-hydroxyquinoline. The absorption spectra showed maximum sharp peaks at 515 nm. The reaction conditions were optimized. Beer's law was followed over the concentration range of 1-12 μg/ml molnupiravir. Job's continuous variation method was developed and the stoichiometric ratio of molnupiravir to 8-hydroxyquinoline was determined to be 1:1. The described method was successfully applied to the determination of molnupiravir in pure form and in pharmaceutical dosage form. The results showed that the proposed method has minimal environmental impact compared to previous HPLC method.
MeSH term(s)	Humans ; COVID-19 ; Spectrophotometry/methods ; Oxyquinoline ; Pharmaceutical Preparations
Chemical Substances	molnupiravir (YA84KI1VEW) ; Oxyquinoline (5UTX5635HP) ; Pharmaceutical Preparations
Language	English
Publishing date	2022-09-22
Publishing country	England
Document type	Journal Article
ZDB-ID	210413-1
ISSN	1873-3557 ; 0370-8322 ; 0584-8539 ; 1386-1425
ISSN (online)	1873-3557
ISSN	0370-8322 ; 0584-8539 ; 1386-1425
DOI	10.1016/j.saa.2022.121911
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Article ; Online: Different spectrophotometric methods for simultaneous determination of lesinurad and allopurinol in the new FDA approved pharmaceutical preparation; additional greenness evaluation.

Abdelazim, Ahmed H / Abourehab, Mohammed A S / Abd Elhalim, Lobna M / Almrasy, Ahmed A / Ramzy, Sherif

Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

2022 Volume 285, Page(s) 121868

Abstract: Lesinurad and allopurinol have been formulated in a combined dosage form providing a new challenge for the treatment of gout attacks. Two mathematical based spectrophotometric methods, area under the curve, and artificial neural networks have been ... ...

Abstract	Lesinurad and allopurinol have been formulated in a combined dosage form providing a new challenge for the treatment of gout attacks. Two mathematical based spectrophotometric methods, area under the curve, and artificial neural networks have been developed for simultaneous determination of lesinurad and allopurinol in pure form and in combined pharmaceutical dosage form. Area under the curve has been utilized to resolve the spectral overlap between lesinurad and allopurinol. Values of area under the curve and area absorptivity were measured at two selected wavelength ranges of 242-250 nm and 255-265 nm. Two mathematically constructed equations have been used to determine the concentrations of the drugs under the study. Advanced chemometry based model, artificial neural network, has been developed utilizing the UV spectral data of lesinurad and allopurinol through various defined steps. A five-level, two-factor experimental design was used to construct 25 mixtures. Thirteen mixtures were used to set up the calibration model and 12 mixtures were used to construct a validation set. The artificial neural network model was optimized to enable precise spectrophotometric determination of the drugs under the study. The described mathematically bases spectrophotometric methods have been successfully applied to the determination of lesinurad and allopurinol in the new combined, Duzallo® tablets. Furthermore, the greenness of the described methods was assessed using four different tools namely, the national environmental method index, the analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The proposed methods showed more adherence to the greenness characters in comparison to the previously reported HPLC method.
MeSH term(s)	Humans ; Allopurinol/therapeutic use ; Gout Suppressants/therapeutic use ; Triazoles ; Gout/drug therapy
Chemical Substances	Allopurinol (63CZ7GJN5I) ; lesinurad (09ERP08I3W) ; Gout Suppressants ; Triazoles
Language	English
Publishing date	2022-09-10
Publishing country	England
Document type	Journal Article
ZDB-ID	210413-1
ISSN	1873-3557 ; 0370-8322 ; 0584-8539 ; 1386-1425
ISSN (online)	1873-3557
ISSN	0370-8322 ; 0584-8539 ; 1386-1425
DOI	10.1016/j.saa.2022.121868
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Simultaneous green TLC determination of nirmatrelvir and ritonavir in the pharmaceutical dosage form and spiked human plasma.

Imam, Mohamed S / Abdelazim, Ahmed H / Batubara, Afnan S / Gamal, Mohammed / Almrasy, Ahmed A / Ramzy, Sherif / Khojah, Hanan / Hasanin, Tamer H A

Scientific reports

2023 Volume 13, Issue 1, Page(s) 6165

Abstract: Quantitative analysis of pharmaceutical compounds up to Nano gram levels is highly recommended to introduce feasible and sensitive tool for determination of the compounds in the pharmaceutical and biological samples. Nirmatrelvir plus ritonavir was ... ...

Abstract	Quantitative analysis of pharmaceutical compounds up to Nano gram levels is highly recommended to introduce feasible and sensitive tool for determination of the compounds in the pharmaceutical and biological samples. Nirmatrelvir plus ritonavir was recently approved in the US, the UK and Europe as a new co-packaged dosage form for the treatment of COVID-19. The objective of this work was to develop a more sensitive TLC method based on using β-cyclodextrin as a chiral selector additive in the mobile phase for simultaneous determination of nirmatrelvir and ritonavir in pure form, pharmaceutical formulation and spiked human plasma. The analysis procedures were developed using TLC aluminum silica gel plates and methanol-water- 2% urea solution of β-cyclodextrin (40:10:.5, by volume) as a mobile phase with UV detection at 215 nm. The developed method was successfully applied over a linearity range of 10-50 ng/band for both nirmatrelvir and ritonavir. The method was validated for limits of detection and quantitation, accuracy, precision, specificity, system suitability, and robustness. Furthermore, the eco-friendliness of the proposed method was assessed using the analytical eco-scale and the green analytical procedure index. The described method exhibited compliance with green analytical chemistry principles based on common green metric values.
MeSH term(s)	Humans ; Ritonavir ; Chromatography, Thin Layer/methods ; COVID-19 ; COVID-19 Drug Treatment ; Pharmaceutical Preparations
Chemical Substances	Ritonavir (O3J8G9O825) ; Pharmaceutical Preparations
Language	English
Publishing date	2023-04-15
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-32904-x
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Article ; Online: Green-adapted spectrophotometric determination of fostemsavir based on selective bromophenol blue extraction; reduction of hazardous consumption using computational calculations.

Batubara, Afnan S / Ainousah, Bayan E / Gamal, Mohammed / Almrasy, Ahmed A / Ramzy, Sherif / Ghoneim, Mohammed M / Abdelazim, Ahmed H

Scientific reports

2023 Volume 13, Issue 1, Page(s) 10049

Abstract: A computationally-assisted and green spectrophotometric method has been developed for the determination of fostemsavir, a recently FDA-approved drug used in combination with antiretroviral drugs to treat multidrug-resistant HIV-1 infection. The method ... ...

Abstract	A computationally-assisted and green spectrophotometric method has been developed for the determination of fostemsavir, a recently FDA-approved drug used in combination with antiretroviral drugs to treat multidrug-resistant HIV-1 infection. The method was developed using computational studies and solvent selection based on green chemistry principles. The density functional theory method was employed to identify bromophenol blue as the preferred acid dye for efficient extraction of fostemsavir. The solvent selection process involved a careful evaluation of the green ranking of solvents, which led to the use of water as the solvent. The method involved the extraction of fostemsavir with bromophenol blue to form a yellow ion-pair complex, which exhibited maximally sharp peaks at 418 nm, enabling sensitive visible spectrophotometric determination of fostemsavir in bulk and pharmaceutical preparations. The extraction procedures were optimized, and the method was demonstrated to be sensitive over the concentration range of 2-12 μg/mL fostemsavir. Furthermore, the method was evaluated with respect to green chemistry principles using the analytical eco-scale, the green analytical method index, and analytical greenness metric approach, all of which confirmed that the data obtained by the proposed method were environmentally acceptable.
MeSH term(s)	Bromphenol Blue ; Spectrophotometry/methods ; Organophosphates ; Solvents
Chemical Substances	Bromphenol Blue (0R2969YC90) ; fostemsavir (97IQ273H4L) ; Organophosphates ; Solvents
Language	English
Publishing date	2023-06-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-36821-x
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Article ; Online: Spectrofluorometric quantitative analysis of aripiprazole based on quenching of natural derived carbon quantum dots in spiked human plasma.

Alaqel, Saleh I / Alqahtani, Arwa S / Alharbi, Adnan / Althobaiti, Yusuf S / Bamaga, Ahmed K / Algarni, Majed A / Almrasy, Ahmed A / Almalki, Atiah H

Scientific reports

2023 Volume 13, Issue 1, Page(s) 21048

Abstract: Autism spectrum disorder is a significant concern worldwide, particularly in Middle Eastern countries. Aripiprazole, a psychiatric medicine that works as a partial agonist at ... ...

Abstract	Autism spectrum disorder is a significant concern worldwide, particularly in Middle Eastern countries. Aripiprazole, a psychiatric medicine that works as a partial agonist at D
MeSH term(s)	Child ; Humans ; Aripiprazole ; Quantum Dots/chemistry ; Carbon/chemistry ; Autism Spectrum Disorder ; Spectrometry, Fluorescence
Chemical Substances	Aripiprazole (82VFR53I78) ; Carbon (7440-44-0)
Language	English
Publishing date	2023-11-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-47392-2
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