Coupling of physical extraction and mathematical filtration in spectrophotometric analysis of natural therapy essential for prophylaxis and treatment of COVID-19 infection - Comparative study along with greenness evaluation.

Diosmin (DIO) and hesperidin (HSP) are important classes of flavonoid glycoside effectively used to prevent comorbid diseases that are commonly associated with COVID-19. An innovative, green, ccurate, effective, cost, and timeless spectrophotometric strategy was established to analyze such challengeable mixture in a co-formulated tablet namely Diosed C® tablets that comprises DIO, HSP and vitamin C (VIT. C) in the ratio of (450 mg: 50 mg: 100 mg) necessary for prevention and treatment of COVID-19. Vitamin C was resolved through physical extraction using de-ionized water while DIO and HSP were extracted via spectrophotometric methods using two different solvents [0.1 M NaOH or solvent blend consisting of DMSO and methanol (1:1)]. Mathematical filtration technique is successfully applied to recover the parent spectra of both DIO and HSP via three methods which are absorbance resolution (AR), Induced absorbance resolution (IAR) and ratio extraction (RE). VIT. C was successfully analyzed in de-ionized water using its maxima at 266.0 nm in a linearity range 2.0-20.0 µg/mL, DIO was effectively determined in 0.1 M NaOH at 372.0 nm in a linearity range of 7.0-70.0 µg/mL as well as in solvent blend at 344.0 nm in linearity range of 5.0-55.0 µg/mL while HSP was accurately analyzed in 0.1 M NaOH at 240.0 nm in linearity range of 3.5-50.0 µg/mL as well as in solvent blend at 285.0 nm in linearity range of 4.0-50.0 µg/mL. Satisfactory results were accomplished when conducting ICH guidelines for assuring the methods validation. Comparative study was introduced in the analysis of such critical combination and was prosperously devoted for the effective analysis of pharmaceutical dosage form. The proposed extraction pathways undergo the guidelines of green analytical chemistry using Analytical Eco-Scale (AES), AGREE and GAPI greenness assessment tools which confirmed their eco-friendly nature with priority to 0.1 M NaOH. The obtained results of the suggested methods were set side by side with those of official/reported methods statistically and show satisfactory implications. The presented methods were simple, affordable, smoothly applicable and their results were acceptable that enhances their usage and application in the quality control laboratories.

Smart stability indicating spectrophotometric methods for determination of modafinil: the promising treatment for post-covid neurological syndrome.

Modafinil (MDF) is one of the neurostimulants with a potential effect in the COVID-19 ICU ventilated patients and post-COVID neurological syndrome treatment. Four rapid, simple and cost-effective stability indicating spectrophotometric methods were used for estimation of MDF in the presence of its acidic degradation product, namely; ratio difference (RD), first derivative of the ratio spectra (1DD), mean centering (MCR) and ratio subtraction method (RS). These methods were validated according to ICH guidelines and all methods revealed a good linearity in concentration range of (5-30 µg/mL) in addition to a good accuracy and precision with mean percentage recovery of 99.97 ± 0.305 for (RD), 100.10 ± 0.560 for (1DD), 100.02 ± 0.483 for (MCR) & 99.18 ± 1.145 for (RS) method. Specificity of the proposed methods was assessed and MDF was determined in the presence of up to 80% of its acidic degradation product for RD, 1DD, MCR and RS methods. The proposed methods were successfully applied for the determination of MDF in bulk powder and its tablet dosage form with mean percentage recovery of 100.33 ± 0.915 for (RD), 100.62 ± 0.985 for (1DD), 99.70 ± 0.379 for (MCR) and 100.21 ± 0.313 for (RS) method. The results obtained were statistically compared with those of official HPLC method and showed no significant difference with relevance accuracy and precision.

Sustainable spectrophotometric determination of antihypertensive medicines reducing COVID-19 risk via paired wavelength data processing technique - Assessment of purity, greenness and whiteness.

Recent studies have reported that using certain antihypertensive therapies such as angiotensin II receptor blockers (ARBs) is associated with mitigation of fatal outcomes and enhancing clinical features of patients having hypertension during coronavirus pandemic. Thus, in the current work an innovative, effective, white and sustainable spectrophotometric technique called paired wavelength data processing technique (PWDPT) was developed for evaluation of recommended antihypertensive combination therapies incorporating candesartan cilexetil (CAN) and hydrochlorothiazide (HCT). This technique included three methods, namely, absorbance resolution (AR), amplitude resolution (PR) and ratio extraction (RE). Linearity ranges were (5.0 µg/mL - 50.0 µg/mL) and (2.0 µg/mL - 24.0 µg/mL) for CAN and HCT, respectively. Validation and confirmation of all suggested methods were conducted in accordance with ICH guidelines, producing satisfactory results within the accepted limits. Statistical comparison was achieved between the attained results from suggested methods and those attained from official methods, in which insignificant difference was existed. The suggested methods were successfully employed for identification of the studied drugs as well as determination of their spectral recognition and evaluation of the purity in their combined formulations. The proposed methods followed the principles of green analytical chemistry, where their greenness was evaluated and compared with the official potentiometric and HPLC methods via using four tools, namely, National Environmental Methods Index (NEMI), the Analytical Eco-Scale, the Green Analytical Procedure Index (GAPI) and Analytical greenness metric (AGREE) which affirmed the eco-friendly nature of the proposed methods. Moreover, studying the whiteness features was performed using the recently introduced RGB12 model. The acceptable results along with the sustainability, simplicity, affordability and low-cost of the proposed methods encourages their utilization in the quality control laboratories.

Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation.

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.

Eco-friendly spectrophotometric evaluation of triple-combination therapies in the treatment strategy of patients suffering from hypertension during coronavirus pandemic - Spectralprint recognition study.

Recent studies have reported that using certain antihypertensive therapies such as angiotensin II receptor blockers (ARBs) and calcium channel blocker (CCBs) is associated with reduction of fatal outcomes and improving clinical characteristics of patients suffering from hypertension during coronavirus pandemic. Thus, in the current work an effective, innovative and eco-friendly spectrophotometric manner namely, parent spectrum extraction (PSE)was established for evaluation of recommended triple antihypertensive combination therapies incorporate valsartan (VAL) as ARBs, amlodipine besylate as CCBs (AML) and hydrochlorothiazide (HCT)as diuretic into single-pill in challengeable ratio. PSE manner composed of two complementary steps, auxiliary resolution coupled with data analysis resolution(DAR)and it is characterized by resolving the spectral bands of the drugs and extraction of their discrete parent spectra (D0); accordingly, enabling determination of each analyte at its λmax. Auxiliary resolution of AML in triple mixture was applied to decrease complexity of overlapped spectra via constant multiplication (CM) followed by spectrum subtraction (SS) to obtain resolved mixture of VAL and HCT while data analysis resolution (DAR) of this binary mixture was applied via one of three novel methods namely, absorbance extraction (AE), peak-amplitude extraction (PE) and ratio extraction (RE) along with SS method. The proposed methods had analyzed VAL, AML and HCT in the range of 4.0-44.0 µg/mL, 4.0-40.0 µg/mL and 2.0-24.0 µg/mL, respectively with an excellent correlation coefficient (r ≥ 0.9999). Further, the proposed methods in PSR manner were validated as stated by ICH guidelines and it was found that accuracy and precision results are within the acceptable limit. The suggested procedures were effectively utilized for the concurrent quantification of VAL, AML and HCT in synthetic mixtures and tablets. The greenness of the proposed spectrophotometric methods was evaluated by National Environmental Methods Index (NEMI), the Analytical Eco-Scale, the Green Analytical Procedure Index (GAPI) and Analytical greenness metric (AGREE) where the four tools affirmed the eco-friendly nature of the proposed methods. A comparison between the outcomes of the studied methods with the official and reported ones was performed and no statistical difference was arisen between the methods regarding to accuracy and precision.The achieved results along with the simplicity, affordability and low-cost of the proposed methods recommended their appropriateness for the regular quality control examination and analysis of pure materials and pharmaceutical formulations as well as their applicability for the spectralprint recognition of the studied drugs.

Chromatographic estimation of a novel triple-therapy combination targeting Helicobacter pylori eradication in different matrices.

Aim: Helicobacter pylori infection is a prevalent global bacterial infection that can potentially exaggerate symptoms of other serious infections like SARS-CoV-2 (COVID-19). Methodology: Herein, an efficient, accurate and cost-effective high-performance liquid chromatography-diode array detector method was developed and validated for determination of the novel triple therapy combination of tinidazole (TD), clarithromycin (CLR) and lansoprazole (LAN) in different analytical matrices (pharmaceutical formulation, dissolution media and spiked human plasma). Results: Successful chromatographic separation was achieved using Agilent Microsorb-MV 100-5 CN column (250 × 4.6 mm, 5 µm) and a mobile phase consisted of acetonitrile and 10.0 mM phosphate buffer, pH 7.5 ± 0.1 at flow rate of 1 ml/min via gradient elution. UV-detection was accomplished at 210.0 nm for CLR and 290.0 nm for TD and LAN. Conclusion: The developed method clearly provides a reliable, beneficial and cost-effective tool for quality control, dissolution testing and biological applications of the mentioned drugs.