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Rapid turbidimetric assay to determine the potency of daptomycin in lyophilized powder

机译:快速比浊法测定达托霉素在冻干粉中的效力

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摘要

Daptomycin is an important antimicrobial for clinical practice, mainly because it remains very active against Gram-positive resistant strains, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. Development of microbiological methods for the analysis of antimicrobials is highly recommended, since they can provide important information about their biological activities, which physicochemical methods are not able to provide. Considering that there are no studies in the literature describing microbiological methods for the analysis of daptomycin, the aim of this work was to validate a microbiological method for the quantitation of daptomycin by the turbidimetric assay. Staphylococcus aureus was used as the test microorganism, and the brain heart infusion broth was used as the culture medium. The validation of the method was performed according to the ICH guidelines, and it was shown to be linear, precise, robust, accurate and selective, over a concentration range of 8.0 to 18.0 µg mL-1. Student's t-test showed the interchangeability of the proposed method with a previously-validated HPLC method. The developed turbidimetric method described in this paper is a convenient alternative for the routine quality control of daptomycin in its pharmaceutical dosage form.
机译:达托霉素是临床实践中的重要抗菌药物,主要是因为它对革兰氏阳性耐药菌株(如耐甲氧西林的金黄色葡萄球菌和耐万古霉素的肠球菌)仍然非常有效。强烈建议开发用于分析抗生素的微生物方法,因为它们可以提供有关其生物学活性的重要信息,而理化方法无法提供这些信息。考虑到在文献中没有描述用于达托霉素分析的微生物学方法的研究,这项工作的目的是验证通过比浊法定量达托霉素的微生物学方法。将金黄色葡萄球菌用作测试微生物,并将脑心浸液肉汤用作培养基。该方法的验证是按照ICH指南进行的,在8.0至18.0 µg mL-1的浓度范围内显示出线性,精确,稳健,准确和选择性。学生t检验显示了该方法与先前验证的HPLC方法的互换性。本文描述的先进的比浊法是达托霉素药物剂型的常规质量控制方法,是一种方便的替代方法。

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