OBJECTIVE: To establish the method for content determination of main component and related substances in Carte-olol hydrochloride oral disintegrating tablets. METHODS: RP-HPLC method was adopted. The separation was performed on a Ultimate XB C18 column with mobile phase consisted of 0.17% dibasic sodium phosphate (pH value adjusted to 3.0 ± 0.05 with 1 mol-L-1 phosphoric acid)-acetonitrile (85:15) at the flow rate of 1 mL·min-1. The detection wavelength was 251 nm and the column temperature was 30℃. RESULTS: Related substances and degraded substances were completely separated from carteolol hydrochloride. The linear range of carteolol hydrochloride was 1.25~40μg·mL-1 (r=0.999 8). The average recoveries of low, middle and high concentration were 101.4% (RSD=0.12%), 101.3% (RSD=0.07%) and 101.4% (RSD=0.03%) (n=3). The LOD was 6.3 ng and LOQ was 20.8 ng. CONCLUSION: The method is simple, rapid, accurate, specific and sensitive, and it is suitable for the content determination of main component and related substances in Carteolol hydrochloride oral disintegrating tablets.%目的:建立测定盐酸卡替洛尔口腔崩解片主药和有关物质含量的方法.方法:采用反相高效液相色谱法.色谱柱为Ultimate XB C18,以0.17％的Na2HPO4溶液(1 mol·L-1的H3PO4调节pH至3.0±0.05)-乙腈(85∶15)为流动相,流速为1 mL·min-1,检测波长为251 nm,柱温为30℃.结果:盐酸卡替洛尔与有关物质及破坏后的降解成分可完全分离；盐酸卡替洛尔检测浓度线性范围为1.25～40.0 μg·mL-1(r=0.999 8);低、中、高3种浓度的回收率(n=3)分别为101.4％ (RSD=0.12％)、101.3％ (RSD=0.07％)、101.4％ (RSD=0.03％)；最低检测限为6.3 ng,最低定量限为20.8 ng.结论:该方法操作简便、快速准确、专属性强、灵敏度高,可用于盐酸卡替洛尔口腔崩解片主药及其有关物质的含量测定.
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