Development and Validation of Reverse Phase HPLC Method for Simultaneous Estimation of Allopurinol and Lesinurad in its API and Pharmaceutical Dosage Form

Sayma Khader, Ayesha Begum K, D. Ramakrishna
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引用次数: 2

Abstract

A new, reliable, and validated reverse phase-high-performance liquid chromatography (HPLC) method was developed to quantify the amount of allopurinol and lesinurad simultaneously in solid (tablet) dosage form. A clear chromatographic division was attained on inertsil ODS (4.6 x 250 mm, 5 mm) column, and a mixture of 0.1% trifluoroacetic acid and methanol in the ratio of 40:60 v/v was used as mobile phase. The rate of flow was set at 1 mL/min, and UV detection was achieved at λmax of 255 nm. Injection volume was set to 20 μL. The correlation coefficient of 0.999 was established, and the accurateness was found to be 100.69 and 100.49 for both the drugs, respectively. Therefore, the developed method was simple, specific, precise, and stable. Hence, the method can be employed to estimate the said drugs in other pharmaceutical formulations.
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别嘌呤醇、Lesinurad原料药及制剂中别嘌呤醇、Lesinurad含量反相高效液相色谱法的建立与验证
建立了一种新的、可靠的、有效的反相高效液相色谱法(HPLC)同时定量固体(片剂)剂型别嘌呤醇和lesinurad的含量。在inertsil ODS (4.6 × 250 mm, 5 mm)柱上,以0.1%三氟乙酸和甲醇的混合物为流动相,以40:60 v/v的比例进行色谱分离。流速为1 mL/min,紫外检测波长为255 nm。注射量设定为20 μL。建立相关系数为0.999,两种药物的准确度分别为100.69和100.49。该方法简便、专属性强、精密度高、稳定性好。因此,该方法可用于估计其他药物制剂中的所述药物。
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