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Isocratic RP-HPLC method for rutin determination in solid oral dosage forms.

机译:等度RP-HPLC法测定固体口服剂型中的芦丁。

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摘要

A rapid and sensitive assay for quantitative determination of rutin in oral dosage forms based on isocratic reversed phase high performance liquid chromatography (RP-HPLC) was developed and validated. Using a C(18) reverse-phase analytical column, the following conditions were chosen as optimal: mobile phase methanol-water 1:1 (v/v), pH 2.8 (adjusted with phosphoric acid), flow rate=1 mL min(-1) and temperature T=40.0 degrees C. Linearity was observed in the concentration range 8-120 microg mL(-1) with a correlation coefficient of 0.99982 and the limit of detection (LOD)=2.6 microg mL(-1), and limit of quantification (LOQ)=8.0 microg mL(-1). Intra- and inter-day precision were within acceptable limits. Robustness test indicated that the mobile phase composition and pH influence mainly the separation. The proposed method allowed direct determination of rutin in pharmaceutical dosage forms in the presence of excipients, but is not suitable for preparations where compounds structurally/chemically related to rutin may be present.
机译:建立并验证了一种基于等度反相高效液相色谱(RP-HPLC)的快速灵敏的定量测定口服剂型中芦丁的测定方法。使用C(18)反相分析柱,选择以下条件为最佳条件:流动相甲醇-水1:1(v / v),pH 2.8(用磷酸调节),流速= 1 mL min( -1)和温度T = 40.0摄氏度。在浓度范围8-120微克mL(-1)中观察到线性,相关系数为0.99982,检出限(LOD)= 2.6微克mL(-1),定量限(LOQ)= 8.0 microg mL(-1)。日内和日间精度在可接受的范围内。稳健性测试表明,流动相的组成和pH值主要影响分离。所提出的方法允许在赋形剂存在下直接测定药物剂型中的芦丁,但不适用于可能存在与芦丁结构/化学相关的化合物的制剂。

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