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

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

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。

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.