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不同定量分析技术在药物制剂中阿司匹林和奥美拉唑含量测定中的应用。

Application of different quantitative analytical techniques for estimation of aspirin and omeprazole in pharmaceutical preparation.

作者信息

Abdelazim Ahmed H, Ramzy Sherif

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Nasr City, Cairo, 11751, Egypt.

出版信息

BMC Chem. 2022 Aug 15;16(1):60. doi: 10.1186/s13065-022-00854-6.

Abstract

Several quantitative analytical methods were used to estimate aspirin and omeprazole in recently FDA-approved tablets. The first derivative of the ratio spectra was used to resolve the recorded overlapping spectra between aspirin and omeprazole. The first derivative of the ratio spectra of the studied drug mixtures was divided by a spectrum of a standard solution of omeprazole for the estimation of aspirin. Also, the first derivative of the ratio spectra of the studied drug mixtures was divided by a spectrum of the standard solution of aspirin for the estimation of omeprazole. For the simultaneous quantitative analysis of aspirin and omeprazole, the TLC densitometry technique was applied using TLC aluminum silica gel plates, toluene-acetonitrile-methanol (7:2:0.5, by volume) as the mobile phase, and UV detection at 272 nm. The advantages and disadvantages of the proposed techniques were discussed in the context of the results and the sensitivity limits of the methods. The proposed techniques were validated and successfully applied to the analysis of drugs in pure and pharmaceutical forms. A statistical comparison of the data obtained by the described methods with other data obtained by a previously published HPLC method was performed. The results agreed well with respect to the recommended statistical tests. Furthermore, the greenness of the described methods was assessed using different tools, the analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The proposed methods showed more adherence to the greenness characters in comparison to the previously reported HPLC method.

摘要

几种定量分析方法被用于测定近期美国食品药品监督管理局(FDA)批准的片剂中的阿司匹林和奥美拉唑。用比率光谱的一阶导数来解析记录的阿司匹林和奥美拉唑之间的重叠光谱。将所研究药物混合物的比率光谱的一阶导数除以奥美拉唑标准溶液的光谱来测定阿司匹林。同样,将所研究药物混合物的比率光谱的一阶导数除以阿司匹林标准溶液的光谱来测定奥美拉唑。对于阿司匹林和奥美拉唑的同时定量分析,采用薄层色谱光密度法,使用薄层色谱硅胶板,以甲苯 - 乙腈 - 甲醇(体积比为7:2:0.5)作为流动相,并在272nm处进行紫外检测。在结果和方法的灵敏度极限的背景下讨论了所提出技术的优缺点。所提出的技术经过验证,并成功应用于纯药物和药物制剂的分析。对通过所述方法获得的数据与先前发表的高效液相色谱(HPLC)方法获得的其他数据进行了统计比较。结果在推荐的统计检验方面吻合良好。此外,使用不同工具,即分析生态规模、绿色分析程序指数和AGREE评估方法,对所述方法的绿色度进行了评估。与先前报道的HPLC方法相比,所提出的方法显示出对绿色度特征的更多遵循。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8954/9380359/c0c7ef3b8e30/13065_2022_854_Fig1_HTML.jpg

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