Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
ISSN: 2157-7064
Department of Chemistry, MSN Pharmaceuticals Inc, USA
Research Article
Validated HPLC method for Identification and Quantification of 4-Hydroxy Benzoic Acid in Levetiracetam Oral Solution Drug Product Formulation
Author(s): MSN Reddy, Gopalakrishnan Venkatasami*, Venkata R Kotta, Muruganantham Ramamoorthy and Shreya Patel
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 t.. View More»