摘要
利巴韦林原料药中相关物质稳定性指示方法的建立与验证
作者(年代):苏巴拉奥·伊达拉,普拉迪普·库马尔,b.m.r o3, m.b.v.s arayana建立了一种简便、准确、精密度高的反相液相色谱法,用于利巴韦林原料药中含量及相关物质的测定。利巴韦林是一种广谱抗病毒药物,对病毒性肝炎、呼吸道感染、出血热等多种病毒性感染均有不同程度的临床疗效。利巴韦林及其相关物质的色谱分离采用YMC- Pack ODS-AQ;150 × 4.6 mm,柱为3µm,缓冲液为1.0g无水硫酸钠和2ml 5%V/V正磷酸,以5%V/V正磷酸调节pH至2.8,流动相为缓冲液为流动相A,流动相为缓冲液:乙腈(95:05% V/V)为流动相B,采用二元梯度模式,流动相流速为1.0 mL/min。样品浓度为0.5 mg/mL。柱温25℃,检测波长220 nm。注入量为5ìL。临界峰对(杂质- a和利巴伐林)的分辨率大于2.0。对于5ìl注射量,杂质- a的检测限(LOD)和定量限(LOQ)为0.1ng/mL,分析物为0.3 ng/mL。试验溶液和流动相在制备48 h后稳定。 The method was validated and found good results of precision, Selectivity and Solution Stability. The proposed method was found to be suitable and accurate for the quantitative determination of the assay and related substances during release and stability testing of Ribavirin active pharmaceutical ingredient.
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