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New spectral resolution techniques for resolving and determining the components in binary fixed-dose combinations

机译:用于解析和确定二进制固定剂量组合中成分的新光谱分辨率技术

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摘要

Four spectrophotometric approaches were performed to determine a binary combination of Phenazone and Benzocaine in pure powder form and in pharmaceutical formations. This investigation submits the application of four techniques contingent on the presence of the extended area of the spectra of one compound in the binary mixture, these methods include Absorptivity Centering (a-centering), Absorbance Subtraction (AS), Amplitude Modulation (AM) and Concentration Value (CV). The linearity range for the above-mentioned approaches was found to be 3.0–15.0 μg/mL for Benzocaine in a-centering method and 3.0–30.0 μg/mL for Benzocaine and Phenazone in other advanced methods. The four techniques were evaluated as per ICH criteria and were successfully utilized for the determination of Phenazone and Benzocaine existing in pharmaceutical formulations. All results gained by the submitted approaches were statistically compared with a previously published method, and no important differences were detected.
机译:进行了四种分光光度法以确定纯粉形式和药物形式的苯那ena和苯佐卡因的二元组合。这项研究提出了四种技术的应用,具体取决于一种化合物在二元混合物中光谱的扩展区域的存在,这些方法包括吸收率中心化(a-centering),吸光度减法(AS),振幅调制(AM)和浓度值(CV)。发现上述方法的线性范围在a-居中法中对苯佐卡因而言为3.0–15.0μg/ mL,在其他高级方法中对苯佐卡因和苯那zone为3.0–30.0μg/ mL。根据ICH标准对这四种技术进行了评估,并成功地用于测定药物制剂中存在的苯那zone和苯佐卡因。将提交的方法获得的所有结果与以前发布的方法进行统计比较,没有发现重要差异。

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