中国药物评价2024，Vol.41Issue(3)：180-184,5.
HPLC法测定复方愈创木酚磺酸钾口服溶液中盐酸异丙嗪相关杂质的研究
Study on HPLC Determination of Impurities Related to Promethazine Hydrochloride in Compound Guaiacol Potassium Sulfonate Oral Solution
摘要
Abstract
Objective:To establish a method for the determination of related substances of promethazine hydrochloride in compound potassium guaiacol sulfonate oral solution.Methods:Using high performance liquid chromatography,the octadecylsilane-bonded silica gel as the stationary phase,0.01 mol·L-1 diammonium hydrogen phosphate solution(pH adjusted to 7.0 by phosphoric acid)-acetonitrile as the mobile phase,gradient elution,The flow rate is 1.0 mL·min-1,the column temperature is 30 ℃,the sample tray temperature is 10 ℃,and the detection wavelength is 249 nm.Results:The impurities A,B,C and D of promethazine hydrochloride and promethazine hydrochloride showed a good linear relationship at 0.115 5～2.310 4,0.100 9～2.018 0,0.116 9～2.338 3,0.109 7～2.194 8,0.416 9～20.847 3 µg·ml-1(r=0.999 9).the average recovery rates of impurities A,B,C,and D of promethazine hydrochloride are 96.2％,96.3％,100.1％,and 100.9％(n=6).Conclusion:The method is simple,has good specificity and reproducibility,and the results are accurate.It can be used as a method for the determination of promethazine hydrochloride related substances in compound potas-sium guaiacol sulfonate oral solution.关键词
HPLC法/复方愈创木酚磺酸钾口服溶液/盐酸异丙嗪/杂质研究Key words
High performance liquid chromatography(HPLC)/Compound guaiacol potassium sulfonate oral solution/Promethazine hydrochloride/Impurity research分类
医药卫生引用本文复制引用
奉艳花,朱荣,杨娜,黄丽丽,陈瀚,赵庄..HPLC法测定复方愈创木酚磺酸钾口服溶液中盐酸异丙嗪相关杂质的研究[J].中国药物评价,2024,41(3):180-184,5.基金项目
广西壮族自治区药品监督管理局药品安全科研项目(桂药监科直局[2023]047号) （桂药监科直局[2023]047号）
