RP-HPLC法测定盐酸卡替洛尔口腔崩解片主药及有关物质的含量

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Ulti-mate XB C18,以0.17%的Na2HPO4溶液(1mo·lL-1的H3PO4调节pH至3.0±0.05)-乙腈(85:15)为流动相,流速为1mL·min-1,检测波长为251nm,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1.25～40.0μg·mL-1(r=0.9998);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6.3ng,最低定量限为20.8ng。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。

Content Determination of Main Component and Related Substances in Carteolol Hydrochloride Oral Disintegrating Tablets by RP-HPLC

OBJECTIVE:To establish the method for content determination of main component and related substances in Carteolol 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 1.25～40 μg·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.