兽药用紫外-可见分光光度法定量土霉素的建立与验证

Jacques Mbuyi Kaluka Tshibamba, Jocelyn Mankulu Kakumba, Timothy Mavanga Mabaya, Roland Marini Djang’ieng’a, J. M. Kindenge
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引用次数: 0

摘要

畜牧业在撒哈拉以南非洲发挥着关键作用,因为它是人类饮食中高价值蛋白质的重要来源,也是社会经济发展的重要驱动力。它代表了一种投资形式,从社会文化角度(仪式、社会地位等)来看也很重要。牲畜是收入、生计、营养和粮食安全的重要来源。然而,畜牧业面临着主要的卫生限制。此外,市场上不合规抗生素的流通对动物健康、公共卫生和环境构成了重大威胁。本研究旨在开发和验证一种紫外-可见光谱法来定量药物土霉素。根据总误差策略,将所开发的方法作为精度剖面中的决策工具进行了验证。完成后,该方法显示出良好的绝对和相对偏差,并且在[-2%,+2%]的可容忍区间内。该方法也具有中等精度的可重复性,其值分别低于2%和4%。我们还评估了该方法的回收率和准确性,认为符合规格限制。在验证后,该方法在47个土霉素注射样品中进行了定量,其中我们获得了28个符合规范的样品和19个不符合规范的样本。这使我们得出结论,从土霉素注射液的常规质量控制来看,所开发的方法是有效的,适用于定量。需要对该方法进行审查,并对其进行相应的重新验证,以用于其他药物展示。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of an ultraviolet-visible spectrophotometric method for quantifying oxytetracycline for veterinary use
Livestock breeding plays a key role in sub-Saharan Africa because it is an important source of highly valued protein in the human diet, and because it is an essential driver for socio-economic development. It represents a form of investment and is also important from a socio-cultural point of view (ceremonies, social position, etc.). Livestock is an important source of income, livelihood, nutrition, and food security. However, livestock breeding faces, among other things, major sanitary constraints. Furthermore, the circulation of non-compliant antibiotics on the market constitutes a major threat to animal health, public health, and the environment. This research aims to develop and validate a UV-vis method for quantifying pharmaceutical oxytetracycline. The method developed was validated following the total error strategy as a decision tool in the accuracy profile. After its completion, the method demonstrated good absolute and relative bias and was within a tolerable interval of [−2%, +2%]. The method was also repeatable with intermediate precision, with respectively lower values than 2% and 4%. We also assessed the recovery and accuracy of the method as fitting with the specification limits. After its validation, the method was quantified in 47 oxytetracycline injectable samples, where we obtained 28 samples complying with specifications and 19 that did not. That led us to conclude that the developed method was validated and appropriate for quantification in terms of the routine quality control of oxytetracycline injection. The method needs to be reviewed and revalidated accordingly for other pharmaceutical presentations.
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