炎立消片含量测定方法的改进  

Improvement of determination of protocatechuic acid in Yanlixiao Tablets by HPLC

作　　者：周琳 ZHOU Lin(Yongzhou Institute for Drug Control Hunan,Yongzhou 425000,China)

机构地区：[1]永州市食品药品检验所,永州425000

出　　处：《中国药品标准》2018年第6期477-481,共5页Drug Standards of China

摘　　要：目的:改进炎立消片中原儿茶酸的含量测定方法。方法:用依利特Hypersil ODS2(4. 6 mm×250 mm,5μm)色谱柱;以甲醇-水-冰醋酸(5∶95∶1)为流动相;流量1. 0 m L·min^(-1);检测波长258 nm;柱温30℃;进样量20μL。结果:原儿茶酸进样量在0. 026～0. 39μg范围内与峰面积呈良好的线性关系(r=0. 999 98),平均回收率为92. 08%,其RSD为3. 66%(n=6)。用本方法和现行标准方法测定3批样品,原儿茶酸含量分别为0. 078 mg·片^(-1)(RSD=1. 2%)、0. 070 mg·片^(-1)(RSD=1. 1%)、0. 066 mg·片^(-1)(RSD=0. 9%和0. 071 mg·片^(-1)(RSD=1. 9%)、0. 063 mg·片^(-1)(RSD=2. 3%)、0. 053 mg·片^(-1)(RSD=2. 1%)。结论:本方法能更准确的测定炎立消片中原儿茶酸含量、大大提高色谱柱使用寿命。Objective: To improve determination of protocatechuic acid in Yanlixiao tablets. Methods: The test was performed on Yilite Hypersil ODS2column( 4. 6 mm × 250 mm,5 μm) under elution of methanol-water-glacial acetic acid( 5∶ 95∶ 1). The flow rate was 1. 0 m L·mim-1,the detection wavelength was 258 nm,the column temperature was 30 ℃ and the injection volume was 20 μL. Results: There was the good linearity in the range of0. 026-0. 39 μg( r = 0. 999 98) between the peak area and concentration of protocatechuic acid. The average recovery was 92. 08% with RSD as 3. 66%( n = 6). Three batches of samples were determined by the improved method and the current method. The contents of protocatechuic acid was 0. 078 mg per tablet( RSD = 1. 2%),0. 070 mg per tablet( RSD = 1. 1%),0. 066 mg per tablet( RSD = 0. 9%); and 0. 071 mg per tablet( RSD =1. 9%),0. 063 mg per tablet( RSD = 2. 3%),0. 053 mg per tablet( RSD = 2. 1%) respectively. Conclusion:The improved method can determine the content of protocatechuic acid in Yanlixiao tablets accurately,and increase the life of column use greatly.

关 键 词：炎立消片 原儿茶酸 含量测定 

分 类 号：R921.2[医药卫生—药学]