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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?g/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%。
A HPLC method was established for the determination of benserazide hydrochloride related substances in dobesilate capsules. The mobile phase was 5.95 mg / ml potassium dihydrogen phosphate solution (containing 1.525 mg / ml sodium decane sulfonate): acetonitrile (79:21) using Merck Purospher star RP-C8 column, adjusted to pH 3.5 with phosphoric acid, Detection wavelength of 220 nm. The results show that the relevant substances in the sample can be detected. Benzathine Hydrochloride, related substances A and B were good linearity in the range of 0.25 ~ 50,1.2 ~ 30 and 0.15 ~ 50? G / ml respectively. The average recoveries of related substances A, B and C were 99.7%, 108.5% and 102.5%, respectively, with RSDs of 5.40%, 2.89% and 3.14%, respectively.