HPLC法测定复方醋酸钠林格注射液中醋酸钠和枸橼酸钠的含量  

Determination of sodium acetate and sodium citrate in compound sodium acetate ringer's injection by HPLC

作　　者：石颖 丁怡[1] 邱娟[1] 李玮玲[1] 章娟[1] SHI Ying;DING Yi;QIU Juan(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国处方药》2023年第8期57-60,共4页Journal of China Prescription Drug

基　　金：广州市市场监督管理局科技项目(2021kj45);广东省药品监督管理局科技创新项目(2020ZDB06)。

摘　　要：目的 建立同时测定复方醋酸钠林格注射液中醋酸钠和枸橼酸钠含量的高效液相色谱法。方法 采用SHIMADZU Shimpack Scepter C18色谱柱(250 mm×4.6 mm,5μm或效能相当的色谱柱);磷酸盐缓冲液(取磷酸二氢钠0.70 g,加水1 000 ml使溶解,加10%四丁基氢氧化铵水溶液2 ml,混匀,用磷酸调节pH至2.0)-甲醇(95∶5)为流动相;流速1.0 ml/min,检测波长210 nm,柱温40℃,记录色谱图至枸橼酸峰保留时间的3倍。结果 醋酸钠浓度在0.167 43~6.697 24 mg/ml范围内线性关系良好(r=1.000 0),定量限为1.8μg/ml,平均回收率99.5%,RSD为0.5%;枸橼酸钠在0.029 42~1.176 95 mg/ml范围内线性关系良好(r=1.000 0),定量限为0.87μg/ml,平均回收率99.7%,RSD为0.4%。结论 该方法简单,准确,灵敏度高,适用于复方醋酸钠林格注射液中醋酸钠和枸橼酸钠的含量测定。Objective To establish an HPLC method for the simultaneous determination of sodium acetate and sodium citrate in compound sodium acetate ringer's injection.Methods The SHIMADZU Shim-pack Scepter C18 column(250 mm×4.6 mm,5 μm) was adopted,the mobile phase was phosphate buffer(0.70 g sodium dihydrogen phosphate was taken and dissolved with 1,000 ml of water,add 2 ml of 10%tetrabutylammonium hydroxide aqueous solution.Adjust with phosphoric acid to a pH of 2.0):methanol(95∶5).The flow rate was 1.0 ml/min,and the detective wavelength was 210 nm.The column temperature was 40℃.Record the chromatogram for 3 times retention time of the citrate acid peak.Results The linear range of sodium acetate was 0.167 43 ~ 6.697 24 mg/ml(r = 1.000 0),the quantification limit was 1.8 μg/ml,the average recovery was 99.5% and the RSD was 0.5%.The linear range of sodium citrate was 0.029 42 ~ 1.176 95 mg/ml,the quantification limit was 0.87 μg/ml,the average recovery was 99.7% and the RSD was 0.4%.Conclusion The method is simple,accurate with high sensitivity,which could be used for the determination of sodium acetate and sodium citrate in compound sodium acetate ringer's injection.

关 键 词：HPLC法 复方醋酸钠林格注射液 醋酸钠 枸橼酸钠 含量 

分 类 号：R927.2[医药卫生—药学]