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 C₁₈ column (3.5 µm 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 µg mL⁻¹, 2–35 µg mL⁻¹, and 1–10 µg 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.

中文翻译：

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开发和验证用于定量分析阿莫西林、双氯西林及其纯品和剂型官方杂质的环保型 HPLC-MS 方法

开发了一种新型、准确、选择性和快速的高效液相色谱质谱法，用于同时分析阿莫西林三水合物、双氯西林钠及其官方杂质 6-氨基青霉酸。将混合物上 C ₁₈柱（3.5  µm ps, 100 mm × 4.6 mm id) 使用乙腈:水（体积比为 65:35）作为流动相，仅需 4 分钟。使用电喷雾电离、选择离子监测和负模式操作的单四极杆质谱仪进行定量分析。阿莫西林、6-氨基青霉烷酸和双氯西林的保留时间分别为 1.61、2.54 和 3.50 分钟。该方法在2-28的线性范围进行了验证 μ克毫升^-1，2-35  μ克毫升^-1和1-10  μ克毫升^-1分别用于阿莫西林、双氯西林和 6-氨基青霉酸。从建议的 HPLC/MS 获得的结果与从报告的 HPLC 方法获得的结果进行统计学比较，在准确度和精密度方面没有出现显着差异。根据分析生态尺度评估方法，所提出的方法被证明比报告的方法更环保，分析时间和废水排放量都减少了。