扑热息痛(PAR)和去氧肾上腺素HCl(PHE)的组合是一种常见的药物组合,旨在控制每天的感冒症状。由于扑热息痛容易降解或一些与制造相关的杂质,应持续监测其稳定性。本研究中开发的在PAR杂质存在下测定PAR和PHE的方法被认为是一种质量评估工具,尤其是当可以定量测定PAR杂质时。优化并验证了毛细管区带电泳(CZE)方法,用于在存在PAR杂质的情况下同时测定PAR和PHE,即对氨基苯酚(PAP),对硝基苯酚(PNP),乙酰苯胺(ACT)和对氯乙酰苯胺(CAC),并进一步定量这些有毒杂质。影响分离质量的因素,如pH,缓冲和施加电压进行了优化。使用20mM磷酸盐缓冲液(pH8)进行分离。在30-250μg/mL的浓度范围内达到线性,1-40μg/mL,2-50μg/mL,2-50μg/mL,PAR为2-50μg/mL和2-50μg/mL,PHE,PAP,PNP,ACT,和CAC,分别,精度范围从99.06%到100.62%。验证后,该方法用于药物制剂分析,RSD<2%。此外,与官方方法的统计比较证实,该方法是该组合质量评估的可行替代方法。
The combination of paracetamol (PAR) and phenylephrine HCl (PHE) is a common pharmaceutical combination intended to manage symptoms of every day cold. Since paracetamol is susceptible to degradation or some manufacturing-related impurities, its stability should be monitored continuously. The developed method in this study for the determination of PAR and PHE in presence of PAR impurities is considered a quality assessment tool especially when PAR impurities can be quantitatively determined. A capillary zone electrophoresis (CZE) method was optimized and validated for simultaneous determination of PAR and PHE in presence of PAR impurities namely, p-Aminophenol (PAP), p-Nitrophenol (PNP), Acetanilide (ACT) and p-Chloroacetanilide (CAC) with further quantification of these toxic impurities. Factors that affect the separation quality such as pH, buffer and applied voltage were optimized. The separation was carried out using 20 mM phosphate buffer (pH 8). The linearity was reached over concentration ranges of 30-250 μg/mL, 1-40 μg/mL, 2-50 μg/mL, 2-50 μg/mL, 2-50 μg/mL and 2-50 μg/mL for PAR, PHE, PAP, PNP, ACT, and CAC, respectively, with accuracy ranging from 99.06% to 100.62%. After validation, the method was applied for pharmaceutical formulation analysis with RSD <2%. Moreover, statistical comparison with the official methods confirms that the method is a viable alternative for quality assessment of this combination.