Posted by admin on Nov 30, 2021 in |
Memantine hydrochloride is a medicine used to medicate patients with moderately severe to severe Alzheimer’s disease and other neurodegenerative disorders; because of mechanisms of neuroprotection, the efficiency of memantine have been delivered in preclinical and clinical experiments. Several approaches for preparing memantine hydrochloride have been announced. The process began with 1,3-dimethyladamantane or 1-bromo-3,5-dimethyladamantane using three or four reaction steps for the production of memantine hydrochloride, with overall yield fluctuating from 39% to 63%. In this article, a concise two-step for the synthesis of memantine hydrochloride from 1,3-dimethyladamantane via 1-acetamido-3,5-dimethyl-adamantane with an overall yield of 85% was developed. The parameters of the procedure were also optimized with a view to lessening the utilization of toxic solvents and reagents, making it more eco-friendly. And in particular, the condition reaction are specified in the preparation of 1-acetamido-3,5-dimethyladamantaneasreaction temperature = 70 ºC, time reaction =2.5 hrs, molar ratio of (acid nitric: acetonitril: 1,3-dimethyladamantane) = 7:10:1; in the synthesis of memantine hydrochloride as reaction temperature = 130 ºC, time reaction = 8 h, molar...
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Posted by admin on Nov 30, 2021 in |
A simple gradient ultrafast liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative estimation of paliperidone in rabbit plasma matrix as per USFDA, and EMA guidelines using a stable isotope-labeled paliperidone-d4 was added as an internal standard. The separation was achieved on a Hypersil BDS C18 column (4.6 mm × 10 cm, 5 µm) with the mobile phase composition of 5 mM ammonium formate in HPLC grade water with 0.05% formic acid (Mobile phase A) and acetonitrile with 0.05% formic acid (Mobile phase B) at a flow rate 1 ml/min in gradient mode. A simple single-step protein precipitation extraction method was adapted using acetonitrile. Quantification of analyte was achieved using positive ionization. Mass ion transitions used were 427.0→207.0 for paliperidone and 431.1→211.0 for paliperidone-d4. The linearity curve was obtained, found to be linear, and the regression coefficient was 0.9990 in the concentration range of 0.25-250 ng/ml. The ruggedness and accuracy of all levels of QC were ranged from 0.81 to 6.02% and 94.22 to 104.40%, respectively....
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Posted by admin on Nov 30, 2021 in |
In Organic chemistry, largest families of organic compounds belong to heterocyclic compounds. In place of a carbon atom incorporation of an oxygen, a nitrogen, a sulfur, or an atom of a related element gives rise to a heterocyclic compound..Heterocyclic compounds are of very essential for our day-to-day life. It has a broad range of applications in medicinal chemistry as well as in agrochemicals products. A Mannich base is a beta-amino-ketone, which is formed in the reaction of an amine, formaldehyde and a carbon acid, and it is a carbon-carbon bond-forming nucleophilic addition reaction and is a key step in synthesis of a wide variety of natural products, pharmaceuticals, and so forth. This literature study enlightens the fact, that Mannich bases of heterocyclic compounds are highly reactive and are recognized to possess potent diverse activities like, anti-inflammatory, anticancer, antibacterial, antifungal, anticonvulsant, anthelmintic, anti-tubercular, analgesic, anti-HIV, antimalarial, antipsychotic, antiviral activities and so forth. In this review various biological activities of Mannich bases of heterocyclic compound derivatives reported is...
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Posted by admin on Nov 30, 2021 in |
A similar biologic product also called biosimilar, follow-on biologic, is highly similar in terms of quality, safety, efficacy with that of the reference product. These are the pharmaceutical products used as the prime treatment options in many chronic diseases and as substitutes for the primary treatment. For development and approval, each nation has adopted its own regulations, and some countries are adopting WHO guidelines. In India Institutional BioSafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Appraisal Committee (GEAC), CDSCO are the competent authorities involved in the approval process. In EU the legal basis of Article 10(4) of Directive 2001/83/EC lays down the requirements for the Marketing Authorization Applications (MAAs) based on the demonstration of the similar nature of the two biological medicinal products. The US Biologics Price Competition and Innovation Act of 2009 (BPCIA) permits the licensing of biological products. During the development process, the biosimilar developer should consider specific parameters like the manufacturing process, demonstrating analytical similarity, which includes structural and functional similarity, interchangeability, and...
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Posted by admin on Nov 30, 2021 in |
A simple, accurate, precise and sensitive first-order UV – Spectrophotometric assay method has been developed and validated for the quantitative estimation of fluvastatin sodium in pharmaceutical dosage forms. The solvent to dissolve the drug and for dilutions, methanol was used. The absorption maxima of fluvastatin sodium in methanol after derivatized into the first-order derivative was found to be 306nm. The drug obeyed Beer’s law in the concentration range of 1 – 5µg/mL with correlation coefficient of 0.9997. The developed method was validated as per the ICH guidelines. The % recovery values were found to be within limits, which showed that the method was accurate. The % relative standard deviation values were less than 2, indicating the method was found to be precise. Limit of detection and limit of quantitation were calculated using statistical methods. The developed method can be used for the quality control of fluvastatin sodium in pharmaceutical dosage...
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