A simple, selective, sensitive, accurate and precise RP-HPLC method was developed for the identification and quantification of 4-hydroxy benzoic acid which is the main degradation product from parabens in Levetiracetam Oral solution. The separation was performed on a C18-column using a mobile phase 0.1% Phosphoric acid buffer as mobile phase A and 100% Acetonitrile as a mobile phase-B in a gradient elution. The detection was performed at a fixed wavelength (λ=230 nm), with a flow rate of 1.0 ml/min. The retention time of 4-Hydroxy Benzoic acid and Levetiracetam were found to be 11.78 min and 9.03 minutes, respectively. After developing the method, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The results of all the parameters of the method were found to be within the acceptance criteria as per the International Council for Harmonization (ICH) guidelines. The detector response was linear in concentrations ranging from 0.5033 μg/mL (0.05%)-4.0264 μg/mL (0.4%) of 4-Hydroxy benzoic acid. The Limit of Detection (LOD) and Limit of Quantification (LOQ) of p-Hydroxy Benzoic acid were found to be 0.1007 μg/mL and 0.5033 μg/mL. The intra and inter day variations were found to be less than 2%. The analytical recoveries of 4-hydroxy benzoic acid are ranges from 94.6% to 107.2%. The proposed method was used to monitor the degradation of the parabens in Levetiracetam Oral solution drug product USP100 mg/5 mL formulation.
Published Date: 2021-11-29; Received Date: 2021-11-08