Abstract A stability-indicating hybrid micelle liquid chromatography accompanied by UV detection was developed for the simultaneous analysis of either paracetamol (PCA) or pseudoephedrine hydrochloride (PSU) with their synthetic impurities. Mixture I contains PCA with p-amino phenol and p-nitro phenol, while mixture II involves the estimation of PSU with benzaldehyde and benzoic acid. Both mixtures were separated using a C18 column that was thermostatically maintained at 40°C and operating under a flow rate of 1.5 mL/min, applying UV detection at 240 nm for mixture I and 220 nm for mixture II. In both cases, the mobile phase consisted of 0.1 M sodium dodecyl sulfate, acetonitrile, and triethylamine (90:10:0.3, v/v/v) and adjusted to pH 4 (mixture I) or pH 3.7 (mixture II) using 2.0 M O-phosphoric acid. The proposed method was validated and successfully applied to assay different pharmaceuticals containing PCA or PSU. Moreover, the stability-indicating nature of the proposed method was proved through applying photolytic degradation procedures for PCA.

中文翻译：

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应用混合胶束液相色谱法分析一些存在合成杂质的药物

摘要 为了同时分析扑热息痛 (PCA) 或盐酸伪麻黄碱 (PSU) 及其合成杂质，开发了一种稳定性指示混合胶束液相色谱法和紫外检测器。混合物 I 包含 PCA 与对氨基苯酚和对硝基苯酚，而混合物 II 涉及使用苯甲醛和苯甲酸估算 PSU。使用恒温保持在 40°C 并在 1.5 mL/min 流速下操作的 C18 柱分离两种混合物，对混合物 I 在 240 nm 处应用 UV 检测，对混合物 II 应用 220 nm。在这两种情况下，流动相均由 0.1 M 十二烷基硫酸钠、乙腈和三乙胺（90:10:0.3，v/v/v）组成，并使用 2.0 调节至 pH 4（混合物 I）或 pH 3.7（混合物 II） M O-磷酸。所提出的方法经过验证并成功应用于检测含有 PCA 或 PSU 的不同药物。此外，通过对 PCA 应用光解降解程序证明了所提出方法的稳定性指示性质。