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

作　　者：奉艳花 朱荣 杨娜 黄丽丽 陈瀚 赵庄 FENG Yan-Hua;ZHU Rong;YANG Na;HUANG Li-Li;CHEN Han;ZHAO Zhuang(GuangXi Institute for Drug Control,Guangxi Nanning 530021,China)

机构地区：[1]广西壮族自治区药品检验研究院,广西南宁530021

出　　处：《中国药物评价》2024年第3期180-184,共5页Chinese Journal of Drug Evaluation

基　　金：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)。

摘　　要：目的:建立复方愈创木酚磺酸钾口服溶液中盐酸异丙嗪有关物质的测定方法。方法:采用高效液相色谱法,以十八烷基硅烷键合硅胶为固定相,以0.01 mol·L^(-1)磷酸氢二铵溶液(磷酸调节pH值至7.0)-乙腈为流动相,梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,样品盘温度10℃,检测波长249 nm。结果:盐酸异丙嗪和杂质A、B、C、D分别在0.1155~2.3104、0.1009~2.0180、0.1169~2.3383、0.1097~2.1948、0.4169~20.8473μg·mL^(-1)呈良好线性关系,相关系数r均为0.9999,杂质A、B、C、D平均回收率分别为96.2%、96.3%、100.1%、100.9%(n=6)。结论:该方法操作简便,专属性和重复性好,结果准确,可作为复方愈创木酚磺酸钾口服溶液中盐酸异丙嗪有关物质的测定方法。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 0.1155~2.3104,0.1009~2.0180,0.1169~2.3383,0.1097~2.1948,0.4169~20.8473μg·ml-1(r=0.9999).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.

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 

分 类 号：R927.12[医药卫生—药学]