摘要:
目的 建立测定盐酸多巴胺预灌装注射液含量的HPLC-ECD方法。 方法 采用Diamonsil-C18柱(250 mm×4.6 mm,5 μm),以0.11%庚烷磺酸钠溶液(含0.1 mmol/L EDTA-2Na及5%冰醋酸,用1 mol/L NaOH溶液调节pH值至3.4)-甲醇(70:30,v/v)为流动相,玻碳电极为工作电极,银/氯化银电极为参比电极,工作电位为+0.65 V,流速1.0 ml/min,柱温20℃。 结果 盐酸多巴胺在0.05~5 μg/ml浓度范围内线性关系良好(r=0.999 9,n=5),平均加样回收率为(99.19±4.03)%(n=3),日内及日间RSD均小于4%(n=3);3批样品中盐酸多巴胺的平均含量相当于标示量的(102.97±1.11)%。 结论 该方法准确、快速、灵敏度高,能够用于盐酸多巴胺预灌装注射液的含量测定。
Abstract:
Objective To establish a HPLC-ECD method for determination of dopamine hydrochloride in prefilled syringe. Methods The determination was performed on a Diamonsil-C18 analytical column (250 mm×4.6 mm,5 μm) with the mobile phase consisting of methanol-0.11% sodium heptanesulfonate solution (containing 0.1 mmol/L EDTA-2Na and 5% glacial acetic acid, adjusting to pH 3.4 with 1 mol/L NaOH). The silver/silver chloride electrode was used as reference electrode and the glassy carbon electrode was used as the working electrode at the potential of+0. 65 V.The flow rate was 1.0 ml/min and column temperature was 20℃. Results The calibration curve of dopamine hydrochloride were linear in the concentration range of 0.05~5 μg/ml (r=0.999 9,n=5). The average recovery rate of dopamine hydrochloride was (99.19±4.03)% (n=3). RSD of intra-day and inter-day were less than 4% (n=3). The contents of dopamine hydrochlorid in three batches of samples were(102.97±1.11)%. Conclusion The method was accurate,rapid and high sensitivity,which was suitable for the determination of dopamine hydrochloride in prefilled syringe.
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