Posted by admin on Jun 30, 2023 in |
Bazedoxifene acetate represents a promising new treatment for osteoporosis. LC-MS SIR (Selective ion recording) mode, the shortest runtime method, was developed and validated for the trace level quantification of two potential genotoxic impurities, i.e., Impurity-A (1 – Benzyloxy – 4 – nitrobenzene) and Impurity – B (4-benzyloxy-2-bromopropiophenone) in Bazedoxifene acetate drug substance. The concentration limits of both genotoxic impurities were calculated a limit of 75ppm based on the concept of TTC (threshold of toxicological concern) and MDD (maximum daily dosage, which is 20mg/day for Bazedoxifene acetate drug substance). The mobile phase used for the method was 10mM Ammonium acetate and acetonitrile in the ratio of (30:70) v/v with isocratic mode elution at flow rate 0.6mL/min, stationary phase used as X-Bridge C18 (50×4.6) mm, 3.5µm and run time was 5 minutes. The Impurities were quantified by using MS detector SIR mode (Selective ion recording) at m/z of 230.12 and 319.01 for Impurity-A and Impurity-B, respectively. The detection limit (DL) was 1.4 ppm for both Impurity-A and Impurity-B. The quantification limit (QL)...
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Posted by admin on Jun 30, 2023 in |
Tinospora sinensis (Lour.) Merr. belongs to the family Menispermaceae is, an important medicinal plant. Ayurveda, an Indian medicinal system, strongly advocates use of T. sinensis as a rejuvenator and several other therapeutic activities. The study’s objectives were to assess the effect of the extraction procedure and different solvent systems on antioxidant, total phenol content and total flavonoid content of T. sinensis. Two conventional extraction methods, cold maceration and Soxhlet extraction, were used to extract four parts of the plant and six different solvent systems viz., petroleum ether, ethyl acetate, chloroform, acetone, ethanol and methanol were used according to their polarity gradient. The total phenolic content was determined using the Folin-Ciocalteau method, and total flavonoid content was determined by aluminium chloride. The antioxidant activity was performed following two in-vitro technique assays, DPPH and ABTS radical scavenging assay. All the extracts of six solvents have potent antioxidant activity and methanol and ethanol extracts showed higher levels. The assimilatory root, stem, root and leaf of T. sinensis possess total phenol and flavonoid...
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Posted by admin on Jun 30, 2023 in |
In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters. Direct compression method was applied for the preparation of ODT containing Brivaracetam using 22 factorial designs with the quantity of drug, pharmabust 500 and crosspovidone as independent variables. Pharmabust 500 and crosspovidone were used as Superdisintegrants. Design Expert 11.0 described adequately impact of selected variables as dependent (pharmabust 500 and crosspovidone) at various levels for response under study (DT and Drug Release at 2 min). Further Optimization of formulation was done using Factorial design (2 factor 2 levels) and established control strategy and design space of the formulation. Design validation was done and final optimized batch P7 was chosen from the design space. The final formulation P7 was tested for Accelerated Stability Studies for 1 month and found stable. As per the results obtained from the experiments, it can be concluded that QbD is an effective and efficient approach for developing quality into ODT...
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Posted by admin on Jun 30, 2023 in |
Background: Imidazole-5-one scaffold has been predicted in the important synthetic drug analogs, which gave valuable information for treatment and high binding affinity to the multiple receptors helpful drug development. Objective: To synthesize and evaluate the anthelmintic, anticancer, and Insilco docking studies of pyrazole contain novel Indole derivatives (4a-4h). Methods: In the present work, we intended to synthesize pyrazole containing novel Indole derivatives (4a-4h) by a conventional method. Results: All the newly synthesized molecules (4a-4h) were characterized by FTIR, 1HNMR, and Mass spectral analysis. The compounds 4c and 4f showed high anthelmintic activity compared with Albendazole as a standard and the compounds 4b, 4e, 4f, and 4g exhibited good anticancer activity against MCF-7 cell line. In molecular docking research, dock rankings of all the synthesized derivatives ranged from -5.972 (compound 4h) to -3.127 (compound 4d). Conclusion: The literature reveals that Imidazole-5-one derivatives have diverse biological activities and a cytotoxic potential to be explored for newer therapeutic...
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Posted by admin on Jun 30, 2023 in |
The importance of flaxseeds in the food sector has been highly appreciated due to the presence of phytochemicals and antioxidants. The aim of the present study was to focus on the effect of different solvents used for the extraction of bioactive phytochemicals from raw, fermented, and germinated deoiled flaxseed flours and also evaluated their antioxidant activities. The phenolic content and flavonoid content of 80% ethanolic extract of germinated deoiled flaxseed flour were greater than the raw and fermented deoiled flaxseed flour. This study also focused on the identification of polyphenol compounds present in flaxseed flour extract which varies due to fermentation and germination processes and showed that germinated deoiled flaxseed flour extracts contained the highest number of polyphenol compounds. The germinated flaxseed flour extract was found to be exhibited at the highest zone of inhibition against S. aureus, B. substilis and E. coli. In our results, it was found that germinated deoiled flaxseed flour extract has higher antiarthritic activities. The study established that both the fermentation and germination processes...
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