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Simultaneous Determination of Active Ingredients in Multicomponent Common Over the Counter Tablets in the Present of Parabens and 4-Aminophenol by HPLC
Chromatographia ( IF 1.2 ) Pub Date : 2020-05-04 , DOI: 10.1007/s10337-020-03886-z
Seyyed Alireza Mousazadeh Hassani

A new selective reverse-phase high-performance liquid chromatography method with an attitude of practical use in pharmaceutical laboratories for simultaneous determination of Ascorbic acid, Acetaminophen, phenylephrine, Caffeine, Pamabrom, Guaifenesin, Dextromethorphan, Pyrilamine, Chlorpheniramine maleate, Ibuprofen in the presence of Methyl, Ethyl, Butyl Parabens as preservatives has been developed and validated. These active pharmaceutical ingredients widely used in a variety of cough and cold medicines. The separation was carried out on an Atlantis dC18 column including 4.6 mm inner diameter, 150 mm length and particle size of 3 μm, using a mobile phase which consisted of an ion-pairing agent (sodium salt of heptane sulphonic acid) as a buffer solution mixed with acetonitrile as an organic modifier at a flow rate of 1 mL min−1 on a gradient system. The investigation was carried out on wavelength program detection to quantify the very low concentration of Dextromethorphan and Chlorpheniramine and high concentration of Acetaminophen, Guaifenesin, Ibuprofen, Ascorbic Acid at the wavelengths of 290 and 215 nm. The temperature was maintained at 40 °C. The method was shown to be linear (R2 > 0.996), accurate (recoveries 97.77–103.94%), precise (RSD ≤ 1.0%), sensitive, specific, simple, fast and robust. The proposed reverse phase-liquid chromatography method was successfully applied to the routine analysis of the Over-The-Counter tablets containing these active pharmaceutical ingredients without any interference with excipients and parabens and 4-aminophenol.

中文翻译:

高效液相色谱法同时测定含有对羟基苯甲酸酯和4-氨基苯酚的多组分常见非处方药片中的活性成分

一种新的选择性反相高效液相色谱方法,具有制药实验室实际应用的态度,可在存在以下物质的情况下同时测定抗坏血酸、对乙酰氨基酚、去氧肾上腺素、咖啡因、巴马溴、愈创甘油醚、右美沙芬、吡拉胺、马来酸氯苯那敏、布洛芬作为防腐剂的甲基、乙基、丁基对羟基苯甲酸酯已被开发和验证。这些活性药物成分广泛用于各种咳嗽和感冒药物中。分离在 Atlantis dC18 柱上进行,柱内径为 4.6 mm,长度为 150 mm,粒径为 3 μm,使用由离子对试剂(庚磺酸钠盐)组成的流动相作为缓冲溶液,在梯度系统上以 1 mL min-1 的流速与作为有机改性剂的乙腈混合。对波长程序检测进行了研究,以在 290 和 215 nm 波长量化极低浓度的右美沙芬和氯苯那敏以及高浓度对乙酰氨基酚、愈创甘油醚、布洛芬、抗坏血酸。温度保持在40°C。该方法显示出线性 (R2 > 0.996)、准确(回收​​率 97.77–103.94%)、精确(RSD ≤ 1.0%)、灵敏、特异性、简单、快速和稳健。
更新日期:2020-05-04
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