Development and Greenness Evaluation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Dorzolamide, Timolol, and Benzalkonium Chloride in Ophthalmic Preparations | ||
| Egyptian Journal of Chemistry | ||
| Articles in Press, Accepted Manuscript, Available Online from 14 September 2025 | ||
| Document Type: Original Article | ||
| DOI: 10.21608/ejchem.2025.409076.12131 | ||
| Authors | ||
| Mohamed El-Kassem Mohamed Hassouna* 1; Alzahraa Shaban Ragab2; Abdelaty Mohamed Radalla3; Samar Mahgoub4; Rehab Khaled Mamoud5 | ||
| 1Chem.Department, Faculty of Science, Beni-Suef University, Beni-Suef, Egypt | ||
| 2Chem. Department, Faculty of Science, Beni-Suef University | ||
| 3Chemistry Dpartment, Faculty of science, Bani-suef university | ||
| 4Materials Science and Nanotechnology Department, Faculty of Postgraduate Studies for Advanced Sciences, Beni-Suef University, Egypt. | ||
| 5Chemistry Department,Faculty of Science, Beni-Suef university, Beni-Suef, Egypt. | ||
| Abstract | ||
| A highly efficient, swift, and straightforward reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of drozolamide hydrochloride (DOR), timolol maleate (TIM), and benzalkonium chloride (BKC) in ophthalmic preparations. Chromatographic separation was achieved in under 15 minutes with retention times of 3.67, 8.82, and 10.81 minutes for DOR, TIM, and BKC, respectively, using an isocratic mobile phase of phosphate buffer (pH 4.2) and methanol (60:40, v/v) at a flow rate of 1 mL/min with detection at 212 nm. The method was rigorously validated as per the ICH and USP guidelines and demonstrated excellent linearity (R² ≥ 0.9986) over a concentration range of 3–50 μg/mL for all analytes. It was highly sensitive, with limits of detection (LODs) of 0.87, 0.94, and 1.12 μg/mL and limits of quantification (LOQs) of 2.64, 2.86, and 3.72 μg/mL for DOR, TIM, and BKC, respectively. The accuracy was exceptional, yielding mean percentage recoveries of 99.96%, 99.87%, and 99.84% from a commercial formulation (Cosopt®). The method's environmental impact was comprehensively evaluated via six assessment tools (NEMI, AGREE, AGREEprep, MoGAPI, BAGI, and RGB12), all of which confirmed its eco-friendly profile. This method presents a rapid, accurate, and sustainable analytical solution for the quality control of this triple combination in pharmaceutical products. | ||
| Keywords | ||
| RP-HPLC; Ophthalmic preparations; Dorzolamide hydrochloride; Timolol maleate; Benzalkonium chloride; Green analytical chemistry | ||
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