Validation of Quantitative Determination Methods for Fexofenadine Hydrochloride and Cyanocobalamine in Separate Ophthalmological Dosage Forms Using UV-Spectrophotometry Instrumentation

E. Zhilyakova, Nabel Mohamad, A. Bakri, D. Naplekov, D. Martseva
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引用次数: 1

Abstract

Aim of this study is validation of quantitative determination methods for Fexofenadine hydrochloride, Cyanocobalamine in separate ophthalmological dosage forms using UV-spectrophotometry instrumentation. Assay tests of the studied ophthalmological dosage forms were carried out using the APIs and reagents of pharmaceutical grade. As APIs, Fexofenadine hydrochloride, Cyanocobalamine were chosen. For dilution of Fexofenadine hydrochloride dosage form, 5% solution of sodium hydroxide and purified water were used. Solution of cyanocobalamine was diluted by purified water. Spectrophotometer SF-104 was used in this study, manufactured in Russia by Akvilon SZ Company. Spectrophotometric cells with optical path length of 10 mm were used for all the measurements. By the obtained experimental data it was established that the proposed assay methods for Fexofenadine hydrochloride and Cyanocobalamine ophthalmological solutions are reliable and valid. The new methods for Fexofenadine hydrochloride and Cyanocobalamine ophthalmological solutions were proposed and successfully validated in from the perspective of specificity, linearity, analytical range, correctness and repeatability. Keywords—Fexofenadine hydrochloride, assay, ophthalmology, UV-spectrophotometry, cyanocobalamine.
紫外分光光度法测定眼用制剂中盐酸非索非那定和氰钴胺含量的方法验证
建立了用紫外分光光度法测定眼用制剂中盐酸非索非那定、氰钴胺含量的方法。采用原料药和医药级试剂对所研究的眼科剂型进行了分析试验。原料药选用盐酸非索非那定、氰钴胺。盐酸非索非那定剂型用5%氢氧化钠溶液和纯净水稀释。用纯净水稀释氰钴胺溶液。本研究使用俄罗斯Akvilon SZ公司生产的SF-104分光光度计。所有测量均使用光程长度为10 mm的分光光度计。实验结果表明,所建立的盐酸非索非那定和氰钴胺眼科溶液的含量测定方法可靠、有效。建立了盐酸非索非那定和氰钴胺眼科溶液的新方法,并从特异性、线性度、分析范围、正确性和重复性等方面进行了验证。关键词:盐酸非索非那定,测定,眼科,紫外分光光度法,氰钴胺
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