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首页> 外文期刊>The Journal of automatic chemistry >Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms
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Development and Validation of Ecofriendly HPLC-MS Method for Quantitative Assay of Amoxicillin, Dicloxacillin, and Their Official Impurity in Pure and Dosage Forms

机译：Ecoxicillin，双氯甲嘧啶，双氧化嘧啶和纯度形式官方杂质定量测定法

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摘要

Novel, accurate, selective, and rapid high-performance liquid chromatography mass spectrometry method was developed for simultaneous analysis of amoxicillin trihydrate, dicloxacillin sodium, and their official impurity 6-aminopenicillanic acid. The chromatographic separation was carried out by applying the mixture on a C_(18) column (3.5? μ m?ps, 100?mm?×?4.6?mm id) using acetonitrile:water (65?:?35 by volume) as a mobile phase within only 4?min. The quantitative analysis was executed using single quadrupole mass spectrometer in which electrospray ionization, selected ion monitoring, and negative mode were operated. The retention times were 1.61, 2.54, and 3.50?mins for amoxicillin, 6-aminopenicillanic acid, and dicloxacillin, respectively. The method was validated in linear ranges of 2–28? μ g?mL~(?1), 2–35? μ g?mL~(?1), and 1–10? μ g?mL~(?1) for amoxicillin, dicloxacillin, and 6-aminopenicillanic acid, respectively. The results obtained from the suggested HPLC/MS were statistically compared with those obtained from the reported HPLC method, where no significant difference appeared respecting accuracy and precision. According to the analytical eco-scale assessment method, the proposed method was proved to be greener than the reported one, where the analysis time and the amount of the wasted effluent decreased.
机译：开发了新颖，准确，选择性和快速的高效液相色谱法，用于同时分析阿莫西林三水合物，双氧化嘧啶钠及其官方杂质6-氨基二甲酸酸。使用乙腈：水（65？：35按体积）将混合物施加在C_（18）塔（3.5Ωμm1s，100Ω×4.4.6μmId）上进行色谱分离仅在4？min内的流动阶段。使用单个四极杆质谱仪进行定量分析，其中电喷雾电离，选择的离子监测和负模式进行了操作。保留时间分别为阿莫西林，6-氨基甲基硅酸和双石唑嗪分别为1.61,2.54和3.50？分别。该方法以2-28的线性范围验证？ μg≤ml〜（α1），2-35？ μg？ml〜（α1）和1-10？用于阿莫西林，双氯甲嘧啶和6-氨基二丙烯酸的μgα1（α1）。与从报道的HPLC方法获得的那些，从建议的HPLC / MS获得的结果与从报道的HPLC方法获得的那些进行了统计学，其中没有显着差异似乎尊重精度和精度。根据分析生态规模评估方法，拟议的方法被证明比报告的方法更环保，其中分析时间和浪费的流出物的量减少。

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