非急性呼吸综合征冠状病毒2型药物法匹拉韦溶出法的研制与验证

IF 0.4 4区 医学 Q4 PHARMACOLOGY & PHARMACY Indian Journal of Pharmaceutical Sciences Pub Date : 2023-01-01 DOI:10.36468/pharmaceutical-sciences.1155
S. Kanithi, N. S. S. P. K. Chebolu, G. N. Challa
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引用次数: 0

摘要

法匹拉韦药物符合抗病毒药物标准,主要用于治疗流感。其机制与病毒核糖核酸依赖核糖核酸聚合酶的选择性抑制有关。采用反相超高效液相色谱法进行定量分析,开发并验证了溶出法和过滤器相容性研究。该方法的验证按照国际协调委员会Q2 (R1)指南在优化的实验条件下进行。色谱柱为Acquity超高效液相色谱HSS C18 (100 mm×1.8 μ),温度为30°,运行时间为8 min。流动相为a-甲醇,b - 0.1%三氟乙酸(v/v)溶于pH=4.8的水中。样品进样量为1 μl,紫外检测波长为210 nm。线性范围为样品浓度水平的1% ~ 300%。新建立的溶出谱在固体剂型中具有良好的重复性和再现性,并证明了过滤器的相容性研究。该方法能够在整个溶出剖面中产生快速的保留时间,并保持井的回收率。该方法可用于质量控制部门固体剂型和活性药物成分的常规定量分析。
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Development and Validation of Favipiravir Severe Acute Respiratory Syndrome Coronavirus 2 Drug by Dissolution Method with Filter Compatibility Study
Favipiravir drug is fitted into antiviral medication criteria and mainly used in the treatment of influenza. The mechanism is associated with choosy inhibition of viral ribonucleic acid-dependent ribonucleic acid polymerase. Development and validation of dissolution method and filter compatibility studies are conducted with reverse phase ultra-performance liquid chromatography method for the quantitative analysis. The validation of this method was performed as per International Council for Harmonisation Q2 (R1) guidelines with the optimized experimental conditions. The proposed method was achieved on Acquity ultra-performance liquid chromatography HSS C18 (100 mm×1.8 μ) column and temperature maintained at 30° and run time was 8 min. The mobile phase consists of A-Methanol, B-0.1 % Trifluoroacetic acid (v/v) in water (pH=4.8). The injection volume of samples was 1 μl and ultraviolet detection was carried out at 210 nm. Linearity ranges were covered from 1 % to 300 % of the sample concentration level. The newly developed dissolution profile will show good repeatability and reproducibility in solid dosage forms and proved the filter compatibility studies. The projected method has capable to produce swift retention time and maintained well percentage recoveries throughout the dissolution profile. Hence this method can be used in customary quantitative analysis in quality control department for solid dosage forms and active pharmaceutical ingredients.
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期刊介绍: The Indian Journal of Pharmaceutical Sciences (IJPS) is a bi-monthly Journal, which publishes original research work that contributes significantly to further the scientific knowledge in Pharmaceutical Sciences (Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Pharmacology and Therapeutics, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Pharmacovigilance, Pharmacoepidemiology, Pharmacoeconomics, Drug Information, Patient Counselling, Adverse Drug Reactions Monitoring, Medication Errors, Medication Optimization, Medication Therapy Management, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest). The Journal publishes original research work either as a Full Research Paper or as a Short Communication. Review Articles on current topics in Pharmaceutical Sciences are also considered for publication by the Journal.
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