Determination of Micro Amounts of Promethazine Hydrochloride in Pure and Pharmaceutical Samples Using UV- Visible Spectrophotometry

I. Humei̇dy
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Abstract

This study presents the development of a novel, facile, and overly sensitive spectrophotometric approach for quantifying promethazine hydrochloride (PRO) within its pharmaceutical formulations. The method capitalizes on an oxidative coupling reaction, achieved through the oxidation of the compound in an acidic milieu utilizing ammonium cerium (IV) sulfate dehydrate (Ce+4) solution. This process leads to the creation of a green-colored solution, which, upon conjugation with 5-aminosalicylic acid, exhibits maximum absorption at a wavelength of 598 nm. The methodology investigated several parameters, encompassing oxidation duration, temperature, quantities of oxidizing agent and coupling reagent, and determining the stoichiometric ratio between promethazine hydrochloride and 5-aminosalicylic acid. The established ratio was confirmed to be 1:1. Numerous organic solvents were evaluated, with water emerging as the optimal choice due to its pronounced absorption characteristics at the 598 nm wavelength. The applicability of Beer's law was verified over a concentration range of 2 - 28 μg/mL of promethazine hydrochloride, with a calculated molar absorption coefficient of 1.9606 x 104 L/mol∙cm. The Sandell sensitivity index was determined as 0.0164 μg/cm2, while the relative standard deviation (RSD) ranged from 0.8553- 1.2671%. Notably, recovery percentages were also within the 99.88 – 100.34% range. The efficacy of this technique was effectively demonstrated through its successful application in the analysis of pharmaceutical formulations containing promethazine hydrochloride, employing the standard method as a benchmark.
利用紫外可见分光光度法测定纯样品和药用样品中盐酸异丙嗪的微量含量
本研究介绍了一种新颖、简便且灵敏度极高的分光光度法,用于定量检测药物制剂中的盐酸异丙嗪(PRO)。该方法利用了氧化偶联反应,在酸性环境中利用脱水硫酸铈铵 (Ce+4) 溶液对化合物进行氧化。这一过程产生了一种绿色溶液,与 5-氨基水杨酸共轭后,在 598 纳米波长处显示出最大吸收。该方法研究了多个参数,包括氧化持续时间、温度、氧化剂和偶联试剂的数量,并确定了盐酸异丙嗪和 5-氨基水杨酸之间的化学计量比。确定的比例为 1:1。对许多有机溶剂进行了评估,水因其在 598 纳米波长处的明显吸收特性而成为最佳选择。在盐酸异丙嗪 2 - 28 μg/mL 的浓度范围内验证了比尔定律的适用性,计算得出的摩尔吸收系数为 1.9606 x 104 L/mol∙cm。桑德尔灵敏度指数为 0.0164 μg/cm2,相对标准偏差(RSD)为 0.8553-1.2671%。值得注意的是,回收率也在 99.88 - 100.34% 之间。该技术以标准方法为基准,成功地应用于含有盐酸异丙嗪的药物制剂的分析,有效地证明了其功效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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