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Abstract：
A new, sensitive, and rapid isocratic reversed phase chromatographic method (RP-HPLC-UV) was developed for simultaneous separation of two newly co-formulated antiulcer mixtures; Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)], and Amoxicillin, Lansoprazole and Clarithromycin [Mixture (II)]. Analytical separation was performed using a Promosil C18 column and ultraviolet detection at 210 nm. The separation was achieved within only 8 min. For both mixtures, an aqueous solution, composed of (Acetonitrile: Methanol: 0. 2 M phosphoric acid) within ratio of (30: 30: 40) adjusted to final pH 3.0, was the mobile phase. This method was validated as per the International Conference on Harmonization guidelines. The linearity ranges of these proposed method of the (Mixture (I)) were 25.0-400.0 µg/mL Amoxicillin, 0.5-8.0 µg/mL Vonoprazan, and 12.5-200.0 µg/mL Clarithromycin. And the linearity ranges of the (Mixture (II)) were 10.0-300.0 µg/mL Amoxicillin, 0.3-9.0 µg/mL Lansoprazole and 5.0-150.0 µg/mL Clarithromycin. This method was firstly applied for effective separation of Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)]. It fulfilled good repeatability, sensitivity, and accuracy (R.S.D. < 2.0%). The mean recoveries of the analytes in their Tri-Pak formulations were acceptable. The greenness of the developed chromatographic methods was assessed using an Eco-scale method and it was applied for content uniformity testing as per the United States Pharmacopoeia (USP) and the acceptance value of Amoxicillin, in Mixture (I) was 2.88, the acceptance values for Amoxicillin, Lansoprazole in Mixture (II) were 2.592, 2.424, respectively.
摘要：
一个新的,敏感,并开发了快速等度反相色谱方法（RP-HPLC-UV），用于同时分离两种新配制的抗溃疡混合物；阿莫西林，沃诺拉赞和克拉霉素[混合物（I）]，和阿莫西林,兰索拉唑和克拉霉素[混合物(II)]。使用PromosilC18柱和210nm的紫外检测进行分析分离。仅在8分钟内实现分离。对于两种混合物，水溶液，由（乙腈：甲醇：0。2M磷酸）在（30：30：40）的比例内调节至最终pH3.0，为流动相。根据国际协调会议准则对该方法进行了验证。（混合物（I））的这些建议方法的线性范围为25.0-400.0µg/mL阿莫西林，0.5-8.0µg/mL伏诺拉赞，和12.5-200.0µg/mL克拉霉素。（混合物（II））的线性范围为10.0-300.0µg/mL阿莫西林，0.3-9.0µg/mL兰索拉唑和5.0-150.0µg/mL克拉霉素。该方法首次用于阿莫西林的有效分离,沃诺拉赞和克拉霉素[混合物(I)]。它满足良好的重复性，灵敏度,和准确性（R.S.D.<2.0%）。分析物在其Tri-Pak制剂中的平均回收率是可接受的。使用Eco-scale方法评估开发的色谱方法的绿色，并根据美国药典（USP）和阿莫西林的接受值将其用于含量均匀性测试，在混合物(I)中为2.88，阿莫西林的接受值为2.88，混合物(II)中的兰索拉唑分别为2.592、2.424。
