XÂY DỰNG VÀ THẨM ĐỊNH QUY TRÌNH ĐỊNH LƯỢNG ĐỒNG THỜI AMLODIPIN BESILAT VÀ INDAPAMID BẰNG PHƯƠNG PHÁP SẮC KÝ LỎNG HIỆU NĂNG CAO ĐẦU DÒ PDA

Abstract

Background: Amlodipine besylate is a substance belonging to the group of calcium channel blockers; indapamide is a diuretic sulfonamide. Numerous benefits result from the combination of these two medications in the bilayer tablet, including simple treatment compliance, high bioavailability, a reduction in the adverse drug reactions associated with each medication, assistance in blood pressure control, and a decrease in cardiovascular events. Consequently, studies that simultaneously measure indapamide and amlodipine besylate must be conducted to assess the amount of active ingredients in tablets. Objectives: To analyze chromatographic conditions, develop, and validate a method to simultaneously quantify amlodipine besylate and indapamide using high-performance liquid chromatography. Materials and methods: Bi-layer tablets containing the active ingredients amlodipine besylate and indapamide, utilizing the experimental research method. Results: HPLC method with PAD detector, reversed-phase Agilent ZORBAX Eclipse Plus C18 column, mobile phase consisting of Acetonitrile: Methanol: triethylamine buffer 0.8% pH 3.0 adjusted with phosphoric acid (ratio 25:30:45, tt/tt), flow rate 1 mL/min, detection wavelength 242 nm. The linear concentration range of amlodipine is 4-20 µg/mL; the regression equation for amlodipine is ŷ = 106.45x with R² = 0.9996; and the linear concentration range of 0.63 µg/mL indapamide is ŷ = 137.27x with R² = 0.999. The RSD of the intraday precision of amlodipine besylate and indapamide were 1.63% and 1.56%, respectively, and the interday precision was 1.86% and 1.39%, respectively. Accuracy was assessed for amodipine besylate and indapamide with RSD of 1.41% and 1.38%, respectively, and recoveries in the range of 98-102%. Conclusion: The HPLC method with the above chromatographic conditions can be applied to simultaneously quantifying amodipine besylate and indapamide.