关键词: font-size:medium, ">HPLC法；复方愈创木酚磺酸钾口服溶液；盐酸异丙嗪；杂质研究

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 potassium guaiacol sulfonate oral solution.

Key words: font-size:medium, ">High performance liquid chromatography(HPLC)； Compound guaiacol potassium sulfonate oral solution；Promethazine hydrochloride；Impurity research