Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Luminescence. 2024 Mar;39(3):e4711. doi: 10.1002/bio.4711.
Ambroxol hydrochloride (AMX) and guaifenesin (GFN) are approved drugs utilized to treat coughs through their potent mucolytic and expectorant properties. Due to their massive, combined administration in many illnesses, there is a persistent need for their concurrent estimation in different pharmaceutical formulations. Two sensitive, environmentally friendly spectrofluorimetric methods were developed. AMX was determined using the first method (I) without interference from GFN. This method depends on the quenching of Erythrosine B (EB) native fluorescence at 552 nm after excitation at 527 nm due to the formation of a non-fluorescent AMX-EB ion-pair complex in Britton-Robinson buffer (BRB) solution pH (3.5). The concentration plot is linear over the 0.25-5.0 μg/mL range, with a mean percent found value of 99.74%. Method (II) depends on measuring the native fluorescence of aqueous GFN solution at two analytical wavelengths, either 300 or 600 nm, after excitation at 274 nm. Relative fluorescence intensity (RFI)-concentration plots are linear over the ranges of 0.02-0.5 and 0.1-2.0 μg/ml, with mean percent found at 99.96% and 99.91% at dual wavelengths, respectively. The proposed methods were successfully applied to assay both drugs in raw materials and different single and combined pharmaceutical formulations. These methods have been thoroughly validated following International Committee on Harmonisation (ICH) guidelines. National Environmental Methods Index, Analytical Eco-Scale, and Green Analytical Procedure Index were used to prove greenness, thereby enhancing their applicability. The proposed techniques provide straightforward, precise, and cost-effective solutions for routine formulation analysis in quality control laboratories.
盐酸氨溴索（AMX）和愈创甘油醚（GFN）是批准用于治疗咳嗽的药物，具有很强的黏液溶解和祛痰作用。由于在许多疾病中大量联合使用，因此持续需要同时评估它们在不同药物制剂中的含量。本文建立了两种灵敏、环保的分光荧光法。第一种方法（I）用于测定 AMX，不受 GFN 的干扰。该方法基于在 Britton-Robinson 缓冲液（BRB）溶液 pH（3.5）中，由于形成非荧光的 AMX-EB 离子对络合物，Erythrosine B（EB）的 native 荧光在 552nm 处被 527nm 激发后猝灭。在 0.25-5.0μg/mL 范围内，浓度与平均发现值的百分比为 99.74%。方法（II）取决于测量水溶液中 GFN 的 native 荧光，在 274nm 激发下，在两个分析波长（300nm 或 600nm）处进行测量。相对荧光强度（RFI）-浓度图在 0.02-0.5 和 0.1-2.0μg/ml 范围内呈线性，在双波长处的平均发现值分别为 99.96%和 99.91%。所提出的方法已成功应用于原料药和不同的单一和组合药物制剂中两种药物的测定。这些方法是按照国际协调委员会（ICH）的指导方针进行了全面验证。国家环境方法指数、分析生态规模和绿色分析程序指数用于证明其绿色性，从而提高其适用性。所提出的技术为质量控制实验室中的常规制剂分析提供了简单、精确且经济有效的解决方案。
