对乙酰氨基酚存在下不同pH介质中三水合阿莫西林的分光光度和高效液相色谱分析

IF 3.4 Q2 PHARMACOLOGY & PHARMACY
Aditi Bala, Sanchita Mandal
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引用次数: 0

摘要

本研究旨在建立一种简单、有效、经济的紫外分光光度法分析对乙酰氨基酚存在下的三水合阿莫西林。三水合阿莫西林、对乙酰氨基酚及其复方在pH为1.2、6.8、7.4和中性(双蒸馏水)的培养基中,浓度范围为2-10µg/ml,均符合Beer-Lambert定律。在联立方程法中,三水合阿莫西林的吸光度最大值在228 nm处,对乙酰氨基酚的吸光度最大值在243 nm处。结果绘制了三水合阿莫西林与对乙酰氨基酚的标准曲线,相关系数(R2)分别在0.991 ~ 0.994和0.993 ~ 0.999范围内。两药以5:3的比例(三水合阿莫西林:对乙酰氨基酚)联合,吸光度在232 nm处达到最大值(等吸收点),根据标准曲线计算其相关系数为0.993 ~ 0.996。上述方法符合ICH指南的所有验证参数,如准确度、精密度、线性度、LOD、LOQ、重现性和回收率。该方法成功地应用于两种药物在没有赋形剂相互作用的情况下的药物剂型组合。本方法是在对乙酰氨基酚存在的情况下,测定三水合阿莫西林在不同pH介质中的稳定性。结论三水合阿莫西林β -内酰胺环在酸性pH(低于2)下发生水解,形成阿莫西林酸,使其微生物活性降低,但在紫外光谱中未出现波长移位和多峰现象。虽然HPLC法在酸性介质中观察到三水合阿莫西林的%面积有一定的变化,但紫外分光光度法在不同pH介质中制备的对乙酰氨基酚与三水合阿莫西林溶液没有明显的变化。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Spectrophotometric and HPLC analysis of amoxicillin trihydrate in presence of acetaminophen in different pH media

Background

This study is aimed to develop a simple, effective and economic method for the UV spectrophotometric analysis of amoxicillin trihydrate in the presence of acetaminophen. The Beer–Lambert law was obeyed in the concentration range of 2–10 µg/ml for amoxicillin trihydrate, acetaminophen and combinations, in all the different pH media: pH 1.2, 6.8, 7.4 and neutral (double-distilled water). For the simultaneous equation method, the absorbance maxima of amoxicillin trihydrate was found at 228 nm, and for acetaminophen, it was found at 243 nm, after scanning the solutions in respective buffers.

Result

The standard curve of amoxicillin trihydrate and acetaminophen was plotted, and the correlation coefficient (R2) value was found to be in the range of 0.991–0.994 and 0.993–0.999, respectively. These two drugs were combined in a ratio of 5:3 (amoxicillin trihydrate: acetaminophen), and its absorbance maxima was discovered at 232 nm (isoabsorptive point), where its correlation coefficient was calculated from the standard curve which is in range of 0.993–0.996. The above-mentioned method was found to comply all the validation parameters as per the ICH guidelines such as accuracy, precision, linearity, LOD, LOQ, reproducibility and recovery. This method is successfully applied to estimate the combination of these two drugs in their pharmaceutical dosage forms without and interaction of their excipients. This method is based on to check the stability of amoxicillin trihydrate in different pH media in the presence of acetaminophen.

Conclusion

Hydrolysis of beta-lactam ring of amoxicillin trihydrate occurs in acidic pH (below 2) which causes the formation of amoxicilloic acid which may cause reduction in its microbial activity but neither shifting of wavelength nor appearance of extra peak occurred in UV spectroscopy. Although some changes of % area of amoxicillin trihydrate is observed in acidic media in HPLC method, there are no significant changes observed among the amoxicillin trihydrate solutions with acetaminophen prepared in different pH media, when using UV spectrophotometric method.

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来源期刊
自引率
0.00%
发文量
44
审稿时长
23 weeks
期刊介绍: Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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