In the present study, a simple, accurate, precise and specific stability-indicating LC method was developed and validated for the quantification of levetiracetam (LEV) in bulk and oral solution. LEV and its degradation products were separated and resolved successfully on C18 column using a methanol:water (30:70 %, v/v) mixture in the isocratic mode at a flow rate of 1 mL/min. All eluents were detected at 205 nm. In forced degradation experiments, LEV was found to degrade significantly in acid, alkali, wet heat, peroxide mediated oxidation, and photolytic conditions, and found stable under dry heat conditions. Validation experiments showed acceptable accuracy, precision, and specificity of the developed method. Assay of the oral solution was in good agreement with the amount of LEV as per the label claim. The method was applied to investigate chemical kinetics under acid and alkali hydrolysis and the pH rate profile of LEV within a range of pH 2 – 12.

在本研究中，开发了一种简单，准确，精确和特异的指示LC的方法，并验证了该方法用于定量散装和口服溶液中左乙拉西坦（LEV）的含量。分离LEV及其降解产物，并使用甲醇：水（30:70％，v / v）混合物以等度模式在C18色谱柱上成功分离，流速为1 mL / min。在205 nm检测到所有洗脱液。在强制降解实验中，发现LEV在酸，碱，湿热，过氧化物介导的氧化和光解条件下会明显降解，并在干热条件下稳定。验证实验表明，所开发方法的准确性，准确性和特异性均可接受。口服溶液的含量与标签要求的LEV含量非常吻合。