HPLC法测定盐酸倍他司汀氯化钠注射液中主药及其有关物质的含量

目的:建立以高效液相色谱法测定盐酸倍他司汀氯化钠注射液主药及其有关物质含量的方法。方法:色谱柱为EclipseXDB-C18,流动相为水(庚烷磺酸钠1g,加三乙胺10mL,水810mL,磷酸调pH3.0)-甲醇(82:18),检测波长为261nm,流速为0.8mL.min-1,柱温为25℃,进样量为50μL。结果:盐酸倍他司汀检测浓度的线性范围为10～80μg.mL-1(r=0.9993);最低检出限为2.84μg.mL-1,最低定量限为3.01μg.mL-1;平均回收率为99.8%,RSD=0.3%;3批样品中有关物质的平均含量为0.13%。结论:本方法简便、快速,结果准确、可靠,可用于该制剂的质量控制。

Quantitative Determination of Main Component and the Related Substances in Betahistine Hydrochloride for Injection by HPLC

OBJECTIVE： To determine the contents of betahistine hydrochloride and the related substances by HPLC. METHODS： The chromatographic separation was performed on Eclipse XDB- C18 column with column temperature at 25 ℃. The mobile phase consisted of water （sodium heptanesulfonate ＋ 10 mL trlethylamine ＋ 810 mL water, with the pH adjusted to 3.0 with phosphoric acid） and methanol （82 ： 18） at a flow rate of 0.8 mL . min ^-1. The detection wavelength was 261 nm and the sample size was 50μL. RESULTS： The linear range of betahistine hydrochloride was 10-80μg . mL^-1（ r = 0.999 3）, The lowest detection limit was 2.84μg . mL^-1 and the lowest quantitative limit was 3.01 μg . mL^ -1. The average recovery was 99,8% （RSD = 0.3% ）. The average content for the related substances in 3 batches of samples was 0.13%. CONCLUSION： The method is simple, rapid, accurate and reliable, and suitable for the quality control of betahistine hydrochloride.