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QUẢNG CÁO
 
Truy cập
Đang online: 4
Tổng số: 448,395
CHI TIẾT
Xây dựng qui trình định lượng đồng thời aspirin, clopidogrel và các tạp chất liên quan bằng phương pháp sắc kí lỏng
Simultaneous determination of clopidogrel, aspirin and related compounds in pharmaceutical formulations by reverse-phase reverse-phase high performance liquid chromatography (RP-HPLC)
Đàm Thị Kim Thoa, Nguyễn Huỳnh Kim Ngân, Roãn Hưng Thuận, Nguyễn Phú Cường, Nguyễn Thị Ngọc Vân
Số: 528 - Tháng 4/2020 - Trang 41-45

Aspirin (ASA) được sử dụng phổ biến như một loại thuốc kháng viêm, nhưng do tác dụng phụ đối với hệ thống tiêu hóa, aspirin đã được thay thế bằng các thuốc kháng viêm không steroid khác an toàn hơn. Tuy vậy, ASA liều thấp vẫn còn được sử dụng rộng rãi do có tác dụng khác là chống kết tập tiểu cầu, ở những đối tượng có nguy cơ tim mạch như người già, người đã đặt stent để ngăn ngừa nguy cơ nhồi máu cơ tim và đột quỵ. Clopidogrel (CLP) là thuốc chống kết tập tiểu cầu được phê duyệt sử dụng vào năm 1998. Việc kết hợp giữa ASA và CLP cho thấy hiệu quả điều trị cao trong nhiều ca lâm sàng. Độ an toàn của thuốc không chỉ phụ thuộc vào độc tính của hoạt chất mà còn phụ thuộc vào độc tính của tạp chất dược phẩm. Sự hiện diện và nồng độ của tạp chất trong chế phẩm có thể là yếu tố nguy cơ cho sự an toàn của bệnh nhân. Một số nghiên cứu trước đây cho thấy acid salicylic (tạp C aspirin) gây nhiễm toan chuyển hóa và kích ứng dạ dày, aspirin anhydride (tạp F aspirin) gây sốc phản vệ thông qua cơ chế miễn dịch. Các phương pháp định lượng ASA và CLP cũng đã được công bố trước đây như HPLC, điện di mao quản, quang phổ Uv –Vis, LC-MS và sắc ký khí. Tuy nhiên, đến nay chưa có nghiên cứu định lượng đồng thời ASA, CLP, tạp C aspirin và tạp F aspirin được công bố. Bên cạnh đó, phương pháp sắc ký lỏng hiệu năng cao là kỹ thuật được sử dụng rộng rãi và thường quy trong việc xác định đồng thời hoạt chất và tạp chất có trong dược phẩm. Do đó, mục tiêu của nghiên cứu sử dụng kỹ thuật HPLC để xây dựng quy trình định lượng đồng thời aspirin, clopidogrel, tạp acid salicylic và aspirin anhydrid trong viên nén kết hợp. Phương pháp được phát triển và thẩm định theo hướng dẫn của ICH.

Nguyên liệu

Chất đối chiếu: ASA (hàm lượng 99,5 %), CLP (hàm lượng 99,3 %), tạp C aspirin (hàm lượng 99,4 %), tạp F aspirin (Toronto, Canada).

Đối tượng nghiên cứu

Viên nén chứa 75 mg ASA và 75 mg CLP (SĐK: VD-20526-14, NSX: Công ty CP. Dược phẩm Đạt Vi Phú (DAVI PHARM), HSD: 08/01/2022).

Phương pháp nghiên cứu

- Khảo sát và lựa chọn điều kiện sắc ký.

- Thẩm định quy trình định lượng: Tính tương thích hệ thống; tính đặc hiệu; Tính tuyến tính, giới hạn phát hiện (LOD), giới hạn định lượng (LOQ) ; Độ đúng và độ chính xác.

- Ứng dụng quy trình.

Kết luận

Nghiên cứu đã xây dựng được quy trình định lượng đồng thời aspirin, clopidogrel và các tạp chất liên quan bằng phương pháp sắc ký lỏng hiệu năng cao UFLC, đầu dò UV-Vis, pha tĩnh C8 (4,6 x 150 mm, 5 μm), pha động gồm acetonitril và đệm acetat pH 3,1 với chương trình rửa giải gradient, thời gian phân tích 13 phút. Quy trình đã được thẩm định có tính đặc hiệu, đạt tính tuyến tính với hệ số tương quan  0,999, giới hạn phát hiện và giới hạn định lượng thấp, đạt độ đúng và độ chính xác. Quy trình đã được ứng dụng để định lượng các chế phẩm viên nén phối hợp trên thị trường.

A RP-HPLC method for simultaneous determination of clopidogrel, aspirin and their related impurities in combined oral formulations was developed and validated as: Column - Agilent ZORBAX Eclipse C8 (150×4.6 mm; 5 μm); Detector – UV (240 nm);  Mobil phase - ammonium acetate buffer 20 nM (pH 3.1)-acetonitrile, in gradient elution mode; Flow rate - 1 ml/min; Run time - < 13 minutes. The method was validated in accordance to the International Conference of Harmonization (ICH) guidelines for clopidogrel, aspirin and its impurities. On practical application, the proposed method proved simple, rapid, precise and accurate, and as such, practically applicable to routine assessment of clopidogrel, aspirin and its impurities in pharmaceutical dosage forms

Quay trở lại

Bản quyền thuộc về Tạp chí Dược học – Bộ Y tế

Địa chỉ: 138 A Giảng Võ - Quận Ba Đình - Thành phố Hà Nội

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