Method Development and Validation studies of Pregabalin Drug by RP-HPLC Method

Eswara Rao Bammidi*¹, Vaikuntarao Lakinani¹, Subrahmanyam Lanka¹, Mallikarjun Rao Duvvada^2
1Departmernt of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatnam, A.P., India
²Departmernt of Environmental Sciences, GITAM Institute of Science, GITAM University

A B S T R A C T
A reverse phase high performance liquid chromatographic method was developed for the determination of related substances in Pregabalin in bulk and pharmaceutical dosage form. The separation was carried out on an Inertsil ODS-3V C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of buffer, acetonitrile and methanol in a gradient elution at a flow rate of 0.8ml/min. The detection was made at 210 nm. The retention time of Pregabalin was found to be 6.5±0.1 min, amine amide impurity was found to be 28.8±0.1 min and lactam impurity was found to be 37.4±0.1min. Calibration curve was linear over the concentration range of 18.75-150 μg/ml of Pregabalin. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative estimation of related substances in drug and pharmaceutical dosage form.
Keywords: Pregabalin, HPLC, Validation studies