Vaborbactam (VBR) and Meropenem (MRP) is a recently approved combination for treatment of complicated urinary tract infection (cUTI). Three different signal processing approaches utilizing UV spectral data has been applied for quality assessment of Vabromere® injection. First, the simplest signal processing method, dual wavelength (DW) was developed, where VBR and MRP were determined at (234.0 & 291.0 nm) and (219.5 & 245.5 nm), respectively. The second one utilized signal processing through derivatization, where, each drug was determined without any interference. This was achieved at 250.0 & 318.0 nm for VBR and MRP, respectively. The third approach is the recently developed algorithm, pure component contribution (PCCA), which efficiently extracts the pure spectrum of each drug and therefore determination is achieved at their λmax with maximum sensitivity and lowest error. The applied methods were found to be linear in the concentration range of 5.00-100.00 μg/mL and 5.00-150.00 μg/mL, for VBR and MRP, respectively. Minimum solvent consumption and diminished preparation or extraction steps are achieved associated with accurate quantitation of VBR and MRP in bulk powders and injection. The developed methods were successfully compared to a reported HPLC method, where no significant difference was found regarding both accuracy and precision.

中文翻译：

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光谱信号处理方法用于选择性定量分析最近获得FDA批准的Vaborbactam和Meropenem的全新组合；用于批量和批量发布的合格评定。

Vaborbactam（VBR）和Meropenem（MRP）是最近被批准的用于治疗复杂尿路感染（cUTI）的组合。三种利用紫外线光谱数据的信号处理方法已应用于Vabromere®注射液的质量评估。首先，开发了最简单的信号处理方法，即双波长（DW），其中VBR和MRP分别确定为（234.0＆291.0 nm）和（219.5＆245.5 nm）。第二种药物通过衍生化处理信号，其中每种药物的测定均不受干扰。对于VBR和MRP，这分别在250.0和318.0 nm处实现。第三种方法是最近开发的算法，纯分量贡献（PCCA），可以有效地提取每种药物的纯光谱，因此可以以最大灵敏度和最小误差在它们的λmax处进行测定。发现所应用的方法对于VBR和MRP分别在5.00-100.00μg/ mL和5.00-150.00μg/ mL的浓度范围内是线性的。与散装粉末和注射剂中的VBR和MRP的准确定量相关的溶剂消耗最少，制备或提取步骤减少。已将开发的方法与已报道的HPLC方法进行了成功比较，后者在准确性和精密度上均未发现明显差异。与散装粉末和注射剂中的VBR和MRP的准确定量相关的溶剂消耗最少，制备或提取步骤减少。已将开发的方法与已报道的HPLC方法进行了成功比较，后者在准确性和精密度上均未发现明显差异。与散装粉末和注射剂中的VBR和MRP的准确定量相关的溶剂消耗最少，制备或提取步骤减少。已将开发的方法与已报道的HPLC方法进行了成功比较，后者在准确性和精密度上均未发现明显差异。