Katib Suphakorn, Apichai Sutasinee, Pattananandecha Thanawat, Jiaranaikulwanitch Jutamas, Sirithunyalug Busaban, Grudpan Kate, Saenjum Chalermpong
Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, Thailand.
Research Center for Innovation in Analytical Science and Technology for Biodiversity Based Economic and Society (I-ANALY-S-T_B.BES-CMU), Chiang Mai University, Chiang Mai, Thailand.
Heliyon. 2024 Apr 17;10(9):e28965. doi: 10.1016/j.heliyon.2024.e28965. eCollection 2024 May 15.
A sustainable procedure offering green, simple, and rapid analysis was developed to determine benzalkonium chloride (BKC) in pharmaceutical preparations. The determination using smartphones was based on the ion pair colorimetric reaction with bromothymol blue (BTB), which produces a yellow color. The intensity of the product color, which is proportional to the concentration of BKC, was detected and evaluated using a smartphone camera and an image processing application. The procedure was performed in a microliter and was rapidly detected within 1 min after incubation. This offered high throughput at 28 samples per well plate in duplicate. Linear calibration, which was a plot of BKC concentrations and relative red intensities, was in the range of 2.0-24.0 μg/mL with an R of 0.997. The limits of detection (LOD) and quantitation (LOQ) were 1.0 and 3.2 μg/mL, respectively. This work was successful in applying it to pharmaceutical materials, disinfectant products, and pharmaceutical products containing BKC. It was discovered that the concentrations of BKC as an active ingredient in pharmaceutical materials were 82% w/v, whereas those in disinfectant products ranged from 0.4 to 2.1% w/v. In pharmaceutical products, ophthalmic drops and nasal sprays contain BKC as preservatives in the 0.01-0.02, and the 0.02% w/v, respectively. The results obtained by the proposed procedure compared with a reference titration method showed no significant differences at a 95% confidence level with 1.2-3.4% RSDs. This promotes the efficiency of pharmaceutical preparations regarding infection prevention and control by ensuring that available disinfectants contain a sufficient concentration of BKC. Additionally, this improves the efficiency of pharmaceutical preparations for quality control of pharmaceutical products by ensuring that the available preservatives maintain a sufficient concentration throughout the lifespan of the products.
开发了一种可持续的方法，用于测定药物制剂中的苯扎氯铵（BKC），该方法绿色、简单且快速。基于与溴百里酚蓝（BTB）的离子对比色反应进行智能手机测定，该反应会产生黄色。使用智能手机摄像头和图像处理应用程序检测并评估与BKC浓度成正比的产物颜色强度。该方法在微升体系中进行，孵育后1分钟内即可快速检测。这实现了高通量，每个微孔板可重复检测28个样品。以BKC浓度和相对红色强度作图的线性校准范围为2.0 - 24.0μg/mL，R为0.997。检测限（LOD）和定量限（LOQ）分别为1.0和3.2μg/mL。该方法成功应用于含BKC的药物原料、消毒产品和药品。发现药物原料中作为活性成分的BKC浓度为82% w/v，而消毒产品中的浓度范围为0.4 - 2.1% w/v。在药品中，眼药水和鼻喷雾剂分别含有0.01 - 0.02% w/v和0.02% w/v的BKC作为防腐剂。将所提出的方法与参考滴定法得到的结果相比，在95%置信水平下，相对标准偏差（RSD）为1.2 - 3.4%，无显著差异。这通过确保现有消毒剂含有足够浓度的BKC，提高了药物制剂在感染预防和控制方面的效率。此外，通过确保现有防腐剂在产品整个保质期内保持足够浓度，提高了药品质量控制中药物制剂的效率。
