分光光度法测定散装和片剂异烟肼的两种新方法

Q3 Pharmacology, Toxicology and Pharmaceutics ACTA Pharmaceutica Sciencia Pub Date : 2019-01-01 DOI:10.23893/1307-2080.APS.05721
O. Adegoke, O. E. Thomas, Deborah Babatunde, O. Oyelami, A. Adediran, Abayomi E. Omotosho
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引用次数: 1

摘要

建立两种新的分光光度法分析散装和片剂异烟肼。方法包括异烟肼与水杨醛缩合和重氮与重氮化对硝基苯胺偶联。对关键因素进行优化;新产物形成的证据,分析波长的选择,温度和时间以及稀释的溶剂。根据ICH指南进行验证。新方法用于异烟肼片的制备。异烟肼与这两种试剂在30℃下反应5 min和20 min后容易形成亚胺和偶氮加合物,分别在405 nm和420 nm处测定。两种方法的检出限均较低,加样回收率均在98%以上。所建立的方法可用于片中异烟肼的含量测定,与官方滴定法测定的含量无显著差异。该方法在制药工业中具有应用前景。
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Two new spectrophotometric methods for the determination of isoniazid in bulk form and tablet dosage form
To develop two new spectrophotometric methods for the analysis of isoniazid in bulk form and tablets. The methods involved condensation of isoniazid with salicylaldehyde and diazo coupling with diazotized p-nitroaniline. Critical factors were optimised; evidence for new product formation, selection of analytical wavelengths, temperature and time and solvent for dilution. Validation was carried out according to ICH guidelines. The new methods were used for isoniazid tablets. Isoniazid formed an imine and azo adduct readily with the two reagents at 30 0C after 5 and 20 mins, and determined at 405 and 420 nm, respectively. Low LODs were obtained for the two methods and recoveries were generally above 98%. The methods were successfully adopted for the assay of isoniazid in tablets and there were no significant differences in the contents when compared with the official titrimetric method of analysis. The methods could find application as in-process method in pharmaceutical industries.
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来源期刊
ACTA Pharmaceutica Sciencia
ACTA Pharmaceutica Sciencia Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
0.90
自引率
0.00%
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0
期刊介绍: Acta Pharmaceutica Sciencia (Acta Pharm. Sci.), formerly known as Bulletin of Pharmacy and Acta Pharmaceutica Turcica is a peer-reviewed scientific journal publishing current research and reviews covering all fields of pharmaceutical sciences since 1953. The original studies accepted for publication must be unpublished work and should contain data that have not been published elsewhere as a whole or a part. The reviews must provide critical evaluation of the state of knowledge related with the subject. All manuscripts has to be written in clear and concise English. Starting from 2016, the journal will be issued quarterly both in paper and on-line formates also publish special issues for national or international scientific meetings and activities in the coverage field.
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