ĐỊNH LƯỢNG ĐỒNG THỜI HYDROCHLOROTHIAZID VÀ IRBESARTAN BẰNG PHƯƠNG PHÁP SẮC KÝ LỎNG HIỆU NĂNG CAO=SIMULTANEOUS QUANTITATIVE DETERMINATION OF HYDROCHLOROTHIAZIDE AND IRBESARTAN BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

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Tác giả: Phú Quý Đoàn, Thị Thu Cúc Lê, Đăng Khoa Nguyễn, Nhật Thanh Nguyễn

Ngôn ngữ: vie

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Thông tin xuất bản: Tạp chí Khoa học và Công nghệ - Đại học Thái Nguyên, 2024

Mô tả vật lý: tr.192 - 198

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ID: 484540

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In this study, an HPLC method for the simultaneous analysis of hydrochlorothiazide and irbesartan in pharmaceutical formulations was developed and validated. The chromatographic separation was performed on a Nucleosil 100 column (250 x 4.6 mm
5 μm). The mobile phase consisted of two solvents: Mobile Phase A (0.1% trifluoroacetic acid in water) and Mobile Phase B (0.1% trifluoroacetic acid in acetonitrile). A gradient elution program was employed with a flow rate maintained at 1.5 mL/min, and the injection volume was set to 20 μL. Detection was carried out at a wavelength of 205 nm. The results demonstrated good linearity (R² >
0.999) with linear regression equations of y = 49739x for HCTZ and y = 118902x for IRB. The accuracy and precision of the method met the required criteria, with an RSD of less than 2%. The average recovery rate ranged from 100.29% to 101.95% for HCTZ and from 99.14% to 100.18% for IRB. The validation data showed that the method was validated according to the guidelines and met the ASEAN requirements for analytical method validation.Trong nghiên cứu này, một phương pháp sắc ký lỏng hiệu năng cao để phân tích đồng thời hydrochlorothiazide và irbesartan trong các công thức dược phẩm đã được phát triển và xác nhận. Phân tách sắc ký được thực hiện trên cột Nucleosil 100 (250 x 4,6 mm
5 μm). Pha động bao gồm hai dung môi: Pha động A (axit trifluoroacetic 0,1% trong nước) và Pha động B (axit trifluoroacetic 0,1% trong acetonitril). Chương trình rửa giải gradient được sử dụng với tốc độ dòng chảy được duy trì ở mức 1,5 mL/phút và thể tích tiêm được đặt ở mức 20 μL. Phát hiện được thực hiện ở bước sóng 205 nm. Kết quả chứng minh tính tuyến tính tốt (R² >
0,999) với các phương trình hồi quy tuyến tính y = 49739x đối với HCTZ và y = 118902x đối với IRB. Độ chính xác và độ tin cậy của phương pháp đáp ứng các tiêu chí yêu cầu, với RSD nhỏ hơn 2%. Tỷ lệ thu hồi trung bình dao động từ 100,29% đến 101,95% đối với HCTZ và từ 99,14% đến 100,18% đối với IRB. Dữ liệu xác nhận cho thấy phương pháp đã được xác nhận theo các hướng dẫn và đáp ứng các yêu cầu của ICH về xác nhận phương pháp phân tích.

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