Simultaneous determination of pregabalin and preservative parabens in pregabalin oral solution by HPLC / 国际药学研究杂志

ABSTRACT

Objective: To develop an HPLC method for simultaneous determination of pregabalin, methylparaben and propylparaben in pregabalin oral solution. Methods: The analytical column was the CPACELL PAK C18 column(250 mm×4.6 mm, 5 μm). The mobile phase A was 25 mmol/L potassium dihydrogen phosphate solution(previously adjusted to pH 6.7 with concentrated ammonia)and the mobile phase B was methanol. Gradient elution was carried out at a flow rate of 1.0 ml/min. The detection wavelength was set at 210 nm for all analytes. The column temperature was maintained at 30℃, and the injection volume was 20 μl. Results: The linear ranges for pregabalin, methylparaben, propylparaben were 1000.45-4001.78, 65.21-260.84, and 8.17-32.68 μg/ml(all r≥0.9995), respectively. Their average recoveries were 100.17%(RSD=1.06%), 100.30%(RSD=0.56%), and 99.92%(RSD=0.28%)(n=9), respectively. Conclusion: The established HPLC method is simply operable, efficient, accurate and reproducible, which could be used for the quantitative determination of pregabalin and paraben preservatives in pregabalin oral solution.