Four rapid, accurate, and validated stability-indicating spectrophotometric methods have been described in the present work for the analysis of trimebutine maleate (TM) in existence of its degradation products in its authentic form and in pharmaceutical formulations excluding any separation steps. These methods were a dual-wavelength (DW) method which allows the determination of TM in existence of its degradation products at 243 nm and 269 nm, second derivative (D2) method measured at peak amplitude at 268 nm, ratio difference (RD) method at 242 nm and 278 nm, and constant center coupled with spectrum subtraction (CC-SS) method at 242 nm and 278 nm versus 278 nm. By applying the suggested methods, TM could be quantified in the range of 5.0–60.0 μg/mL with percentage recoveries 99.97 ± 0.40, 100.36 ± 0.58, 99.90 ± 0.42, and 100.15 ± 0.45 for DW, D2, RD, and CC-SS methods, respectively. International Conference on Harmonization guidelines were followed for validation of the described methods, and the application of laboratory-prepared mixtures along with different pharmaceutical drugs including the target drug showed favorable results without any contribution from additives. Statistical comparison was used to compare the proposed and official methods, and satisfactory results for both accuracy and precision were obtained. The results confirm the applicability of the suggested methods for the determination of TM in quality control laboratories.

中文翻译：

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用于分析马来酸曲美布汀及其降解产物的结构解析的重叠光谱的不同方面

在本工作中，已经描述了四种快速，准确和经过验证的稳定性指示分光光度法，用于分析曲美布汀马来酸酯（TM）是否存在其降解形式的可靠产品以及不包括任何分离步骤的药物制剂。这些方法是双波长（DW）方法，可用于测定243 nm和269 nm处降解产物存在时的TM，在268 nm峰值处测量的二阶导数（D2）方法，比率差（RD）方法分别在242 nm和278 nm处进行分析，并且在242 nm和278 nm与278 nm处进行恒定中心耦合光谱减法（CC-SS）。通过采用建议的方法，TM的定量回收率可以在5.0–60.0μg/ mL的范围内，DW，D2的回收率分别为99.97±0.40、100.36±0.58、99.90±0.42和100.15±0.45。分别采用RD和CC-SS方法。遵循国际协调会议指南对所描述的方法进行验证，实验室制备的混合物以及包括目标药物在内的不同药物的应用均显示出良好的效果，而添加剂没有任何贡献。统计比较用于比较建议的方法和官方方法，并获得了令人满意的准确性和精确度结果。结果证实了建议的方法在质量控制实验室中测定TM的适用性。实验室制备的混合物与包括目标药物在内的不同药物一起使用均显示出良好的效果，而添加剂没有任何贡献。统计比较用于比较建议的方法和官方方法，并获得了令人满意的准确性和精确度结果。结果证实了建议的方法在质量控制实验室中测定TM的适用性。实验室制备的混合物与包括目标药物在内的不同药物一起使用均显示出良好的效果，而添加剂没有任何贡献。统计比较用于比较建议的方法和官方方法，并获得了令人满意的准确性和精确度结果。结果证实了建议的方法在质量控制实验室中测定TM的适用性。