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Green spectrofluorimetric assay of dantrolene sodium via reduction method: application to content uniformity testing.

ABSTRACT: Green analysis has turned out to be of a great value in all areas, including pharmaceutical analysis. Thus, it is extremely important to consider the environmental influence of each step in developing any analysis technique. The present work illustrates a validated, simple and green spectrofluorimetric method for the analysis of dantrolene sodium (DAN). The developed process is characterized by being of high sensitivity as well as being relatively inexpensive. The suggested technique based on the formation of a highly fluorescent product of DAN via its reduction by the aid of Zn/HCl system. The resulting fluorophore showed a powerful fluorescence at λ _em 344 nm after excitation at λ _ex 279 nm. Calibration graph revealed a great linear regression (r = 0.9998) within concentration ranging from 0.05 to 2.0 µg ml^-1. The suggested method had very low detection and quantification limits of 0.010 and 0.031 µg ml^-1, respectively. The applied technique was effectively used in the determination of DAN in its pharmaceutical preparations. The results were compared with those from using the official United States Pharmacopeia (USP) method and they were in a good agreement. Moreover, content uniformity testing of DAN in capsules was performed adopting the investigated technique with satisfying results. The greenness of the suggested technique was confirmed by the three standard assessment tools. Therefore, the developed technique can be used in the routine quality control analysis of DAN with minimum harmful impact on nature or individuals.

SUBMITTER: Abdalah NA

PROVIDER: S-EPMC8278042 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The greenness of any analytical method has become a very important aspect of a good analytical method. However, most chromatographic methods depend on the usage of relatively large amounts of lethal and un-decaying chemicals and solvents. So, a green approach based on the full factorial design was employed to develop a simple and rapid HPLC technique for concurrent determination of paracetamol and dantrolene sodium in their combined capsules. Both drugs are highly recommended to be administered together in patients with severe musculoskeletal disorders. Avoiding the routine methodology and resorting to the modern technology represented in the usage of experimental design allows rapid determination of the studied drugs using the optimum quantity of chemicals to avoid any waste of resources. Simultaneous separation of a binary mixture of paracetamol and dantrolene sodium was accomplished using a reversed phase Hypersil C18 column using an eco-friendly isocratic eluent. The used mobile phase consisted simply of ethanol: water (40:60, v/v). Orthophosphoric acid was used to adjust the pH of the mobile phase to 4.5. Triethanolamine (0.2%) was added aiming to reduce the peak tailing. The assay was completed within less than 6 min adopting 0.8 mL/min as a flow rate. The detection was carried out using a UV-detector at 290 nm. The suggested technique shows a linear correlation over concentration ranges of 1.0-200 and 1.0-40 µg/mL for paracetamol and dantrolene sodium, respectively. The suggested technique allowed the simultaneous analysis of the two co-formulated drugs in their synthetic mixture and combined capsule. The suggested technique is considered a greener substitute for the other reported HPLC techniques through the usage of safer solvents and chemicals, along with decreasing both waste output and analysis time. The method is accurate with recoveries between 97.85 and 101.27%, precise, as %RSD for the intraday and interday precision were between 0.39 and 1.72% and very sensitive with limits of detection (LOD)'s 0.15 and 0.18 µg/ml and limits of quantification (LOQ)'s 0.48 and 0.61 µg/ml for paracetamol and dantrolene sodium, respectively. The method greenness was ensured through its assessment by four greenness metrics. It is also validated following the International Conference on Harmonization Guidelines. The recommended technique could be a good alternative to traditional methods in the routine quality control analysis of the studied drugs due to its minimum harm to the planet or human beings.

Project description:A green, quick and sensitive spectrofluorimetric technique was investigated and validated for the assay of three different drugs namely, ketoprofen (KPN), paracetamol (PAR), and chlorzoxazone (CLX). The method is based on fluorescence quenching of the fluorescence probe, silver nanoparticles (SNPs). The fluorescence quenching of SNPs may be attributed to the complexation between each of the studied drugs with SNPs. The fluorescence of SNPs alone or after complexation with the studied drugs were measured at 485 nm (λ ex 242 nm) without the need to extract the formed complex. Chemical reduction was employed for preparing SNPs, where silver nitrate was reduced by sodium borohydride in deionized water without adding organic stabilizer. SNPs were found soluble in water, had high stability and had a narrow emission band. The studied drugs were found to decrease the fluorescence of SNPs significantly through static quenching according to Stern-Volmer equation. Factors affecting the reaction between the drugs and NPs were carefully examined and optimized. Using the optimum conditions, the difference in the fluorescence intensity of SNPs before and after complexation with the studied drugs was in a good linear relationship with the concentration of the studied drugs, where (R 2 = 0.9998, 0.9998 and 0.9991) in the ranges of 0.5-5.0, 0.15-3.0 and 0.5-9.0 μg mL-1 for KPN, PAR and CLX, respectively. Validity of the proposed method was investigated according to ICH recommendations. The proposed technique was also employed for the analysis of each of the three drugs in commercial or laboratory prepared tablets and in spiked human plasma with very good recoveries as well as high level of accuracy and precision. This method was intended to the analysis of the proposed drugs in their single formulation and single drug administration. The suggested technique is considered an eco-friendly method, as it uses water as the safest and least expensive solvent. Moreover, the recommended technique does not involve solvent extraction of the formed complexes. Greenness assessment of the suggested procedure was accomplished by applying the four standard assessment tools. Consequently, the recommended method can be used in the routine quality control analysis of the cited drugs with minimum harmful effect on the environment as well as the individuals.

Project description:BACKGROUNDWolfram syndrome is a rare ER disorder characterized by insulin-dependent diabetes mellitus, optic nerve atrophy, and progressive neurodegeneration. Although there is no treatment for Wolfram syndrome, preclinical studies in cell and rodent models suggest that therapeutic strategies targeting ER calcium homeostasis, including dantrolene sodium, may be beneficial.METHODSBased on results from preclinical studies on dantrolene sodium and ongoing longitudinal studies, we assembled what we believe is the first-ever clinical trial in pediatric and adult Wolfram syndrome patients with an open-label phase Ib/IIa trial design. The primary objective was to assess the safety and tolerability of dantrolene sodium in adult and pediatric Wolfram syndrome patients. Secondary objectives were to evaluate the efficacy of dantrolene sodium on residual pancreatic β cell functions, visual acuity, quality-of-life measures related to vision, and neurological functions.RESULTSDantrolene sodium was well tolerated by Wolfram syndrome patients. Overall, β cell functions were not significantly improved, but there was a significant correlation between baseline β cell functions and change in β cell responsiveness (R2, P = 0.004) after 6-month dantrolene therapy. Visual acuity and neurological functions were not improved by 6-month dantrolene sodium. Markers of inflammatory cytokines and oxidative stress, such as IFN-γ, IL-1β, TNF-α, and isoprostane, were elevated in subjects.CONCLUSIONThis study justifies further investigation into using dantrolene sodium and other small molecules targeting the ER for treatment of Wolfram syndrome.TRIAL REGISTRATIONClinicalTrials.gov identifier NCT02829268FUNDINGNIH/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (DK112921, DK113487, DK020579), NIH/National Center for Advancing Translational Sciences (NCATS) (TR002065, TR000448), NIH training grant (F30DK111070), Silberman Fund, Ellie White Foundation, Snow Foundation, Unravel Wolfram Syndrome Fund, Stowe Fund, Eye Hope Foundation, Feiock Fund, Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from NIH/NCATS, Bursky Center for Human Immunology & Immunotherapy Programs.

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Green spectrofluorimetric assay of dantrolene sodium via reduction method: application to content uniformity testing.

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