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Analytical method development and validation for the determination of Levetiracetam in pharmaceutical formulations by using RP-HPLC

机译:RP-HPLC测定药物制剂中左乙拉西坦的分析方法开发和验证

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A simple, reproducible and efficient reversed phase high performance liquid chromatography (RP-HPLC) method has been developed for estimation of a recently approved anti epileptic drug, Levetiracetam in raw material and its pharmaceutical formulations. Separation was done by using mobile phase consisting of diphasic sodium phosphate buffer and acetonitrile in a ratio of 80:20. The separations were carried out on an Inertsil C18 column (250x 4.6mm; 5μm) at a flow rate of 1.5 ml/min. The injection volume was 10 μl and the peaks were detected at 205nm. The linear dynamic response was found to be in the concentration range of 80 μg -130 μg/ml and coefficient of correlation was found to be 0.9994. The percentage recovery of levetiracetam was found to be 98.37%. The proposed method was found to be simple, fast, accurate, precise and reproducible and could be used for routine quality control analysis of levetiracetam in bulk and pharmaceutical dosage forms.
机译:已经开发出一种简单,可重现和高效的反相高效液相色谱(RP-HPLC)方法,用于估算原料及其药物制剂中最近批准的抗癫痫药左乙拉西坦。使用流动相进行分离,该流动相由比例为80:20的双相磷酸钠缓冲液和乙腈组成。在Inertsil C18色谱柱(250x 4.6mm;5μm)上以1.5 ml / min的流速进行分离。进样量为10μl,在205nm处检测到峰。线性动态响应被发现在80μg-130μg/ ml的浓度范围内,相关系数被发现为0.9994。发现左乙拉西坦的回收率为98.37%。发现该方法简单,快速,准确,精确且可重现,可用于散装和药物剂型左乙拉西坦的常规质量控制分析。

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