Xây dựng và thẩm định quy trình định lượng đồng thời indapamid và perindopril tert-butylamin trong viên nén bằng phương pháp sắc ký lỏng hiệu năng cao=Developing and validating of rp-hplc method for simultaneous quantification of indapamide and perindopril tert-butylamine in tablets

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Tác giả: Thị Lan Linh Đinh, Thành Nghĩa Nguyễn

Ngôn ngữ: vie

Ký hiệu phân loại:

Thông tin xuất bản: Tạp chí Khoa học và Công nghệ - Đại học Nguyễn Tất Thành, 2024

Mô tả vật lý: tr.175

Bộ sưu tập: Báo, Tạp chí

ID: 249344

Thêm vào giỏ

Hypertension is the world’s leading cause of death. The number of people with hypertension, particularly at a young age, is constantly increasing. The proportion of patients with uncontrolled hypertension also grows due to ineffective monotherapy. Therefore, the use of fixed-dose combination drugs such as Indapamide (IND – Thiazid-like) and Perindopril tert-butylamine (PER – ACE inhibitor) has become common. However, the Pharmacopoeia from Viet Nam and from other countries do not include specific guidelines on the process of simultaneous quantification of these 2 substances. Thus, this study was conducted to develop and validate the simultaneous quantification process of Indapamide and Perindopril tert-butylamine in tablets by high-performance liquid chromatography (HPLC). A method has been developed for the simultaneous quantification of Indapamide and Perindopril tert-butylamine with mobile phase consisting of acetonitril/0.01 % perchloric acid water (33:67), HiQ sil C18HS column (250 mm × 4.6 mm, 5 μm), column temperature 35 °C, flow rate 1.2 mL/min, injection 10 μl, detecter PDA, and wavelength 215 nm. Sample processing conditions: ethanol extraction, no ultrasonication. The method has been validated according to the ICH guidelines, including: system suitability
specificity
linearity from (5-35) ppm and (10-100) ppm, respectively for Indapamide and Perindopril tert-butylamine (R >
0.9999)
the detection limit and the quantitative limit for Indapamide and Perindopril tert-butylamine were 0.59 ppm and 1.79 ppm, and 1.47 ppm and 4.45 ppm respectively
accuracy (recovery rate of (98.0-102.0) %)
precision (RSD <
2.0 %).Nghiên cứu này được thực hiện nhằm xây dựng và thẩm định quy trình định lượng đồng thời indapamid và perindopril tert-butylamin trong viên nén bằng phương pháp sắc ký lỏng hiệu năng cao (HPLC) phù hợp với điều kiện cơ sở vật chất sẵn có. Một phương pháp đã được xây dựng để định lượng đồng thời indapamid và perindopril tert-butylamin với pha động gồm acetonitril-nước acid percloric 0,01 % (33:67), pha tĩnh là cột HiQ sil C18HS (250 mm × 4,6 mm, 5 µm), nhiệt độ cột 35 ℃, tốc độ dòng 1,2 mL/phút, thể tích tiêm mẫu 10 µL, đầu dò PDA, bước sóng phát hiện 215 nm. Điều kiện xử lý mẫu: chiết bằng ethanol, không siêu âm. Phương pháp đã được thẩm định đạt yêu cầu theo hướng dẫn của ICH gồm tính phù hợp hệ thống
độ đặc hiệu
tính tuyến tính từ (5-35) ppm và (10100) ppm lần lượt cho indapamid và perindopril tert-butylamin với hệ số tương quan R >
0,9999
giới hạn phát hiện và giới hạn định lượng lần lượt là 0,59 ppm và 1,79 ppm với indapamid và 1,47 ppm và 4,45 ppm với perindopril tert-butylamin
độ đúng, tỷ lệ thu hồi (98,0-102,0) %
độ chính xác SD <
2,0 %.

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