Development and Validation of RP-HPLC Method for Simultaneous Estimation of Piracetam and Vinpocetine

Abstract

Designed for the simultaneous estimation of Piracetam (PIRA) and Vinpocetine (VINP) combination a validated Reversed Phase-High-Performance Liquid Chromatography (RP-HPLC) method was developed. The separation and analysis were performed on a reversed phase C18 column (250 mm×4.6 mm) with particle size 5 μm as the stationary phase. The mobile phase selected was consisting of potassium dihydrogen phosphate buffer (0.05M, pH 6.0): methanol (50: 50, v/v) with flow rate 1.0 ml/min. For the detection of analytes, 225 nm was selected as suitable wavelength. The retention times of 3.52 min and 7.41 min was found for PIRA and VINP respectively. The proposed method exhibited good linearity over the concentration range of 80–480 μg/ml for PIRA and 2–12 μg/ml for VINP. The correlation coefficient (r2) value of 0.999 and 0.996 for PIRA and VINP were found respectively. The ICH Q2 (R1) guidelines were followed for validation of this developed method. The % recovery of piracetam and vinpocetine was found 101.38 ± 0.71% and 102.04 ± 0.58%. The % RSD for the method was found to be less than 2 shows the technique is precise one. The developed method was precise, accurate, robust, selective and rapid for simultaneous estimation of PIRA and VINP. Finally, the optimized method was used for analysis of in-house bilayered tablet formulation. The percentage purity was found to be 103.63 ± 0.02 for VINP and 100.92 ± 0.67 for PIRA in a tablet.