血清素接收抑制剂抗抑郁药物的分子吸收扫描与分析

IF 0.7 4区 医学 Q4 PHARMACOLOGY & PHARMACY Current Pharmaceutical Analysis Pub Date : 2024-02-05 DOI:10.2174/0115734129282354231226192406
Amanda Santana Silva, Victor Hugo Abreu de Paula, Lucas Gabriel dos Santos Xavier, Ludimila Nascimento da Silva, Ana Carolyne Silva Lucas, Aléxia Mariany Lourenço Alves, Fernando Machado dos Santos
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引用次数: 0

摘要

背景::分光光度法基于被分析物质分子对电磁能量的吸收,可用于药物分析。目的::本研究拟对巴西三家实验室生产的 5-羟色胺再摄取抑制剂类抗抑郁剂仿制药进行分子吸收扫描和紫外光谱分析,探讨良好生产规范、药品质量控制以及定性和定量分析技术使用的重要性。方法使用 Marte Científica (580 UVP) 紫外可见分光光度计进行理化分析,并根据《巴西药典》规定的验收间隔对结果进行评估。结果在计算盐酸氟西汀样品的剂量时,得到的数值为 90.95%,因此,该药物获准进行剂量试验。药物氢溴酸西酞普兰和盐酸舍曲林的剂量测试也获得了批准,分别获得了 102.4% 和 98.2% 的数值。结论这些结果为今后严格执行良好的药品处理规范、维护和鉴定质量控制实验室设备以及保证验证制药行业使用的分析方法提供了参考,有助于提高生产和药品分析的质量。
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Molecular Absorption Scanning and Assay of Serotonin Reception Inhibitor Antidepressant Drugs
Background:: Spectrophotometric techniques are based on the absorption of electromagnetic energy by the molecules of the substance analyzed and can be applied to drug analysis. Objective:: This study has been proposed to carry out molecular absorption scanning and assay in the ultraviolet region of generic antidepressant drugs of the serotonin reuptake inhibitor class produced by three Brazilian laboratories, addressing the importance of good manufacturing practices, drug quality control, and the use of qualitative and quantitative analytical techniques. Methods:: The physicochemical analyses were performed in a Marte Científica (580 UVP) UV-Vis spectrophotometer, and the result was evaluated according to the acceptance interval described in the Brazilian Pharmacopoeia. Results:: When calculating the dosage of the fluoxetine hydrochloride sample, the value of 90.95% was obtained and, therefore, the drug was approved for the dosage test. The dosage test for the drugs, citalopram hydrobromide and sertraline hydrochloride, was also approved, obtaining values of 102.4% and 98.2%, respectively. Conclusion:: The results presented provide future perspectives regarding the rigor of the need for good drug handling practices, maintenance and qualification of quality control laboratory equipment, and the guarantee of validation of analytical methodologies used in the pharmaceutical industries, contributing to the improvement of the quality of production and pharmaceutical products analysis.
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来源期刊
CiteScore
1.50
自引率
0.00%
发文量
85
审稿时长
3 months
期刊介绍: Aims & Scope Current Pharmaceutical Analysis publishes expert reviews and original research articles on all the most recent advances in pharmaceutical and biomedical analysis. All aspects of the field are represented including drug analysis, analytical methodology and instrumentation. The journal is essential to all involved in pharmaceutical, biochemical and clinical analysis.
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