高效液相色谱法同时测定普瑞巴林口服溶液中普瑞巴林及羟苯酯类抑菌剂含量

Simultaneous determination of pregabalin and preservative parabens in pregabalin oral solution by HPLC

目的建立同时测定普瑞巴林口服溶液中普瑞巴林及抑菌剂羟苯甲酯、羟苯丙酯的高效液相色谱(HPLC)分析方法。方法HPLC色谱柱CPACELL PAK C18(250 mm×4.6 mm,5μm),以25 mmol/L磷酸二氢钾溶液(氨水调节pH至6.7)为流动相A,甲醇为流动相B,进行梯度洗脱,流速1.0 ml/min,检测波长为210 nm,柱温30℃,进样量20μl。结果普瑞巴林、羟苯甲酯、羟苯丙酯分别在1000.45~4001.78μg/ml、65.21~260.84μg/ml、8.17~32.68μg/ml浓度范围内呈良好线性关系(r均≥0.9995),平均回收率(n=9)分别为100.17%(RSD=1.06%)、100.30%(RSD=0.56%)、99.92%(RSD=0.28%)。结论所建立的HPLC法简便高效、结果准确、重复性好,可用于测定普瑞巴林口服溶液中普瑞巴林及羟苯酯类抑菌剂的含量。

Objective To develop an HPLC method for simultaneous determination of pregabalin,methylparaben and propylparaben in pregabalin oral solution.MethodsThe analytical column was the CPACELL PAK C18 column(250 mm×4.6 mm,5μm).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 20μl.ResultsThe linear ranges for pregabalin,methylparaben,propylparaben were 1000.45-4001.78,65.21-260.84,and 8.17-32.68μg/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.