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Tổng hợp và xác định độ tinh khiết tạp chất liên quan D (ethyl 5-amino-1H-pyrazol-4-carboxylat) của Alopurinol / Nguyễn Trần Vân Anh, Lữ Thiện Phúc, Phạm Lê Ngọc Yến, Nguyễn Đức Tuấn // Tạp chí Dược học . - 2018. - tr. 32-36. - ISSN:



Ký hiệu phân loại (DDC): 615
Allopurinol impurity D (ethyl 5-amino-1H-pyrazole-4-carboxylate) was synthesized from ethyl (ethoxymethylene) cyanoacetate and hydrazine in the yield of 61.3 % (0.28 gram). By using HPLC – PDA, its chromatographic purity was determined over 99.0 %. As such, the obtained allopurinol impurity D was fairly satisfactory for establishment of the reference substance. Moreover, an HPLC method for purity determination of impurity D was developed as: column - XtimateR C18 (5 µm; 250 4.6 mm); Detector – UV (247 nm; Mobile phase - methanol and water (40:60, v/v); Flow rate - 1.0 mL/min. Validation in observance to ICH guidelines, the method showed to hand wide linearity range (25.16 – 503.10 µg/ml), high precision (RSD £ 0.03 %). The method showed good selectivity, wide linearity range and high precision.
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