多巴丝肼胶囊有关物质的HPLC法测定

Determination of Related Substances In Levodopa and Benserazide Hydrochloride Capsules by HPLC

建立了高效液相色谱法测定多巴丝肼胶囊中盐酸苄丝肼的有关物质.采用Merck Purospher star RP-C8色谱柱,流动相为5.95 mg/ml磷酸二氢钾溶液（含癸烷磺酸钠溶液1.525 mg/ml）∶乙腈（79∶21）,用磷酸调至pH 3.5,检测波长220 nm.结果显示样品中的有关物质均能检出.盐酸苄丝肼、有关物质A和B分别在0.25～50、1.2～30和0.15～50 μg/ml浓度范围内线性关系良好.有关物质A、B、C的平均回收率分别为99.7％、108.5％和102.5％,RSD分别为5.40％、2.89％和3.14％.

An HPLC method was established for the determination of the related substances in levodopa and benserazide hydrochloride capsules.A Merck Purospher star RP-C8 column was used,with the mobile phase of 5.95 mg/ml potassium dihydrogen phosphate solution （containing 1.525 mg/ml sodium decanesulfonate） ∶ acetonitrile （79 ∶ 21）,adjusted to pH 3.5 with phosphoric acid,at the detection wavelength of 220 nm.The resolution between the peaks of benserazide hydrochloride and related substances was good.The calibration curves for benserazide hydrochloride,related substances A and B were linear in the concentration ranges of 0.25-50,1.2-30 and 0.15-50 μg/ml.The average recoveries of related substances A,B and C were 99.7％,108.5％ and 102.5％,with RSDs of 5.40％,2.89％ and 3.14％,respectively.