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=Development and validation of HPLC-PDA method for the simultaneous determination of amlodipine besylate and indapamide

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Tác giả: Thị Mỹ Duyên Huỳnh, Thị Minh Ngọc Lê, Trọng Hoàng Long Mai, Mạnh Quân Nguyễn, Trần Vĩnh Khang Nguyễn, Võ Đại Tiến Phạm, Thành Thông Võ

Ngôn ngữ: vie

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Thông tin xuất bản: Tạp chí Y dược học Cần Thơ, 2024

Mô tả vật lý: tr.1-7

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ID: 245085

Thêm vào giỏ

Amlodipin besilat là thuốc thuộc nhóm chẹn kênh canxi, indapamid là một sulfonamid lợi tiểu, sự kết hợp giữa hai thuốc này trong cùng một dạng bào chế mang lại nhiều ưu điểm như dễ tuân thủ điều trị, cho sinh khả dụng cao, hạn chế tác dụng không mong muốn của từng loại thuốc giúp kiểm soát được huyết áp và làm giảm biến cố tim mạch. Do đó, việc nghiên cứu định lượng được đồng thời amlodipin besilat và indapamid cần được thực hiện để làm cơ sở để đánh giá hàm lượng hoạt chất trong sản phẩm bào chế. Mục tiêu nghiên cứu: Khảo sát điều kiện sắc ký, xây dựng và thẩm định phương pháp định lượng đồng thời amlodipin besilat và indapamid bằng phương pháp sắc ký lỏng hiệu năng cao đầu dò PDA. Đối tượng và phương pháp nghiên cứu: Phương pháp nghiên cứu thực nghiệm trên thành phẩm viên nén chứa đồng thời hoạt chất amlodipin besilat và indapamid. Kết quả: Phương pháp HPLC với đầu dò PAD, cột Agilent ZORBAX Eclipse Plus C18 pha đảo, pha động gồm Acetonitril:Methanol:đệm triethylamin 0,8% pH 3,0 điều chỉnh bằng acid phosphoric (tỉ lệ 25:30:45, tt/tt), tốc độ dòng 1 mL/phút, bước sóng phát hiện 242 nm. Khoảng nồng độ tuyến tính amlodipin là 4-20 μg/mL, phương trình hồi qui của amlodipin là ŷ = 106,45x với R2 = 0,9996 và khoảng nồng độ tuyến tính là 0,6-3 μg/mL indapamid là ŷ = 137,27x với R2 = 0,999. RSD của độ chính xác trong ngày amlodipin besilat và indapamid lần lượt là 1,63% và 1,56% và độ chính xác liên ngày lần lượt là 1,86% và 1,395%
độ đúng được thẩm định của amodipin besilat và indapamid với RSD lần lượt là 1,41% và 1,38% và độ thu hồi trong khoảng 98-102%. Kết luận: Phương pháp HPLC với điều kiện sắc ký trên có thể được áp dụng để định lượng đồng thời amodipin besilat và indapamid.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 0.6- 3 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.

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