HPLC测定盐酸拉贝洛尔的含量及有关物质

Determination of Content and Related Substances of Labetalol Hydrochloride by HPLC

关键词:  盐酸拉贝洛尔  含量测定  有关物质  高效液相色谱法

Key words:  labetalol hydrochloride  content determination  related substances  HPLC

摘要:

目的 建立盐酸拉贝洛尔的含量测定及有关物质的检查方法。方法 采用高效液相色谱法，色谱柱为Agilent TC-C₁₈柱(250 mm×4.6 mm，5 μm)，以甲醇-0.1 mol·L^-1磷酸二氢钠溶液(55∶45)为流动相，柱温为50 ℃，流速为1.0 mL·min^-1，检测波长为230 nm。结果 盐酸拉贝洛尔峰与盐酸拉贝洛尔酮峰及强制破坏产生的降解产物峰均分离良好；盐酸拉贝洛尔在43.39~390.5 μg·mL^-1内与峰面积呈良好线性关系，r=1.000；回收率为99.8%(RSD=0.50%，n=9)；最低检出限为0.853 6 ng；供试品溶液在24 h内稳定。结论 该方法专属性强，准确、灵敏，可用于盐酸拉贝洛尔的含量测定和有关物质检查。

Abstract:

OBJECTIVE To establish a method to determine the content and related substances of labetalol hydrochloride. METHODS HPLC was adopted on an Agilent TC-C₁₈ column(250 mm×4.6 mm, 5 μm) using an isocratic mobile phase consisting of methanol-0.1 mol·L^-1 monosodium phosphate (55∶45) with a flow rate of 1.0 mL·min^-1. The column temperature was kept at 50 ℃ and the detection wavelength was set at 230 nm. RESULTS The resolution between the peaks of labetalol hydrochloride and labetalone hydrochloride and other peaks was good. The concentration-response relationship was linear over the range of 43.39-390.5 μg·mL-1(r=1.000). The average recovery was 99.8%(RSD=0.50%, n=9) and the limit of detection was 0.853 6 ng. The solution was stable for 24 h. CONCLUSION The method is specific, accurate, sensitive and can be used for the determination of content and related substances of labetalol hydrochloride.