中国药房2012，Vol.23Issue(9)：829-831,3.DOI:10.6039/j.issn.1001-0408.2012.09.21
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
摘要
Abstract
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.关键词
盐酸卡替洛尔/口腔崩解片/含量/有关物质/反相高效液相色谱法Key words
Carteolol hydrochloride/ Oral disintegrating tablets/ Content/ Related substances/ RP-HPLC分类
医药卫生引用本文复制引用
聂延君,罗永煌,刘艳玲,田朋鑫..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[J].中国药房,2012,23(9):829-831,3.基金项目
重庆市科技计划项目(CSTC,2009CB1010) （CSTC,2009CB1010）
