Department of Biomedical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Saudi Arabia.
Department of Quality Assurance, Krupanidhi College of Pharmacy, Bengaluru 560035, India.
Molecules. 2020 Oct 19;25(20):4793. doi: 10.3390/molecules25204793.
Widespread presence of pharmaceuticals and their metabolites in the environment of industrialized countries is an emerging global concern. Potential contamination of the soil and water by such pharmacologically active substances poses serious ecotoxicological implications. Several studies assessing the long-term ecological risks of pharmaceutical contaminants mainly focus on the risk assessment of the parent drug, while the potential contributions of their metabolites is often neglected. Presence of selective serotonin and norepinephrine reuptake inhibitor venlafaxine, an antidepressant drug, and its metabolites is a matter of serious concern for aquatic systems, since they are difficult to remove by traditional wastewater treatment processes. The concentration of VEN present in water is reportedly one of the highest among pharmaceuticals; however, the long-term effects of its metabolites have not yet been systematically studied. Given the consideration to complex and time-consuming effluent treatment, and realizing the importance of levels of venlafaxine and its metabolites, a simple and accurate analytical method for quick determination is needed. We designed a selective colorimetric method by using oxidative coupling of drug molecules with 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) reagent, to quantify the presence of venlafaxine and its metabolites in aquatic samples, with special emphasis on effluent. The method was validated for selectivity, specificity and robustness as per the ICH Q2 guidelines to assess its suitability in pharmaceutical samples, as well. Highly sensitive and green economical analytical method was successfully established for estimation of venlafaxine and its metabolites in aquatic samples. The method was quick, as it involved minimum processing steps. The method was accurate and linear in the range of 0.5 to 80 ppm and could successfully detect lowest concentration of 1.3 ppm, thus qualifying its applicability for the desired purpose to check the presence of trace levels of VEN or its metabolites in aquatic samples or in pharmaceutical formulations.
在工业化国家的环境中，药品及其代谢物的广泛存在是一个新出现的全球性问题。这些具有药理活性的物质有可能污染土壤和水，这带来了严重的生态毒理学影响。一些评估药物污染物长期生态风险的研究主要侧重于评估母体药物的风险，而往往忽略了其代谢物的潜在贡献。作为一种抗抑郁药的选择性 5-羟色胺和去甲肾上腺素再摄取抑制剂文拉法辛及其代谢物的存在，是水生系统严重关切的问题，因为它们很难通过传统的废水处理过程去除。据报道，水中 VEN 的浓度是所有药物中最高的之一；然而，其代谢物的长期影响尚未得到系统研究。考虑到复杂且耗时的废水处理，以及认识到文拉法辛及其代谢物水平的重要性，需要一种简单、准确的分析方法来快速测定。我们设计了一种选择性比色法，通过药物分子与 3-甲基-2-苯并噻唑啉酮腙盐酸盐（MBTH）试剂的氧化偶联，来定量测定水中文拉法辛及其代谢物的存在，特别强调了废水。该方法按照 ICH Q2 指南进行了选择性、特异性和稳健性验证，以评估其在药物样品中的适用性。该方法成功建立了一种用于在水生样品中估计文拉法辛及其代谢物的高灵敏度和绿色经济的分析方法。该方法快速，因为它只涉及最少的处理步骤。该方法在 0.5 至 80 ppm 的范围内具有高度灵敏性和线性，并且可以成功检测到 1.3 ppm 的最低浓度，因此可以应用于检查水生样品或药物制剂中痕量 VEN 或其代谢物的存在。
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