Micelle Incorporated Liquid-Chromatography in the Light of Green Chemistry: an Application for the Quality Control Analysis of anti-Platelet Fixed-Dose Combinations

• Published in: Journal of AOAC International Vol. 105; no. 5; pp. 1228 - 1233
• Main Authors: Elsonbaty, Ahmed, Hassan, Wafaa S, Eissa, Maya S, Abdulwahab, Sara
• Format: Journal Article
• Language: English
• Published: England 06.09.2022
• Subjects: aspirin; Brij-35; clopidogrel Bisulphate; salicylic acid; Micellar Liquid chromatography
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoacint/qsac046

Oral anti-platelet agents are the cornerstone of treatment of multiple cardiovascular diseases and in the long-term prevention of their recurrence. In the present work, we report a method based on micellar liquid chromatography coupled with ultraviolet detection (MLC/UV), for the simultaneous quantification of combined anti-platelet therapy namely, clopidogrel bisulphate (CPS), aspirin (ASP), together with salicylic acid (SA), in their pharmaceutical dosage form. The incorporation of 0.1M polyoxyethylene 23 lauryl ether (Brij-35) as a surfactant into the mobile phase improved solute-mobile phase interaction allowing for minimal organic solvent utilization, enhanced resolution, and rapid analysis (7 min). Furthermore, we performed a comprehensive evaluation of the environmental impact caused by our procedures versus previously reported analytical procedures applied in the determination of CPS and ASP, evaluation was done by employing Eco-scale tool. Results of the developed method indicated superioty of our procedures in term of greenness, without compromising the quality of performance characteristics. The method was linear in the range of 1-100 µg/mL with limits of detection of 0.28, 0.32, and 0.29 µg/mL for CPS, ASP, and SA respectively. The developed method can also be utilized to test the purity and the stability of ASP in pharmaceutical formulations through monitoring SA as its main degradation product. The developed MLC/UV method was successfully applied for quantitative analysis of CPS, ASP together with SA-as a main degradation product of ASP-in their pharmaceutical dosage form.