HPLC同时测定复方利血平片中5个成分的溶出度  

Determination of the dissolution of five components in Compound reserpine tablets by HPLC

作　　者：张玉娟 张晓明 张柏桃 ZHANG Yujuan;ZHANG Xiaoming;ZHANG Botao(Gansu Institute for Drug Control,Lanzhou,Gansu,730070 P.R.China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070

出　　处：《华西药学杂志》2023年第1期100-104,共5页West China Journal of Pharmaceutical Sciences

基　　金：甘肃省药品科研项目(2021GSMPA0011)。

摘　　要：目的 采用HPLC法测定复方利血平片的溶出度。方法 用Capcell Pak MGⅡ-C_(18)色谱柱(150 mm×4.6 mm, 5μm),以0.02 mol·L^(-1)磷酸二氢钾溶液(含0.2%己烷磺酸钠,磷酸调pH2.7)-甲醇为流动相,梯度洗脱,检测波长220 nm,进样量100μL。结果 氢氯噻嗪、盐酸异丙嗪、硫酸双肼屈嗪、维生素B_(6)和维生素B_(1)等的线性范围分别为0.8~20.7、1.6~40.0、1.4~34.7、1.3~31.6、1.2~29.9μg·mL^(-1),r分别为0.9996、0.9998、0.9986、0.9998、0.9998;平均回收率分别为98.6%、101.4%、103.3%、98.4%、99.4%;检测限分别为0.148、0.766、1.306、0.605、1.135μg·mL^(-1);供试品溶液在9 h内稳定。结论 所用方法简便快捷,准确可靠,可用于复方利血平片的质量控制及体外质量一致性评价。OBJECTIVE To determine the dissolution of Compound reserpine tablets by HPLC.METHODS The method was performed on a shiseido Capcell Pak MGⅡ-C_(18)(150 mm×4.6 mm, 5 μm) column, with a mobile phase consisting of a mixture of 0.02 mol·L^(-1)monopotassium phosphate solution containing 0.2% sodium hexanesulfonate(adjust pH to 2.7 with phosphoric acid) and methanol by gradient elution at a flow rate of 1.0 mL·min^(-1).The column temperature was 35 ℃ and the detection wavelength was set at 220 nm.RESULTS Hydrochlorothiazide, promethazine hydrochloride, dihydralazine sulfate, vitamin B_(6)and vitamin B_(1) revealed good linearity over the ranges of 0.8-20.7,1.6-40.0,1.4-34.7,1.3-31.6 and 1.2-29.9 μg·mL^(-1),respectively, with r of 0.9996,0.9998,0.9986,0.9998 and 0.9998,respectively.The average recoveries of hydrochlorothiazide, promethazine hydrochloride, dihydralazine sulfate, vitamin B6and vitamin B1were 98.6%,101.4%,103.3%,98.4% and 99.4%,respectively.The limit of detections were 0.148,0.766,1.306,0.605 and 1.135 μg·mL^(-1),respectively.The solution was stable within 9 h with good durability.CONCLUSION The method is simple, rapid, accurate and reliable.It could be used for the quality control of Compound reserpine tablets and in vitro quality consistency evaluation.

关 键 词：复方利血平片 氢氯噻嗪 盐酸异丙嗪 硫酸双肼屈嗪 维生素B_(6) 维生素B_(1) 溶出曲线 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]