高效液相色谱法测定正骨消肿止痛凝胶中阿魏酸的含量及制剂稳定性考察  

Determination of Ferulic Acid in ZhengGu XiaoZhong ZhiTong Gel by HPLC and the Investigation of its Stability

作　　者：林银凤 黄炜东 池秀珍 杨真真[2] 黄贵红 徐端琼 LIN Yin-feng;HUANG Wei-dong;CHI Xiu-zhen;YANG Zhen zhen;HUANG gui-hong;XU duan-qiong(Quanzhou Institue for Food and Drug Control,Quanzhou 362000,China;Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University,Quanzhou 362000,China)

机构地区：[1]福建省泉州市食品药品检验所,泉州362000 [2]福建中医药大学附属泉州市正骨医院,泉州362000

出　　处：《海峡药学》2023年第12期25-28,共4页Strait Pharmaceutical Journal

基　　金：2021年福建省市场监督管理局科技项目(项目编号FJMS2021035)。

摘　　要：目的建立测定正骨消肿止痛凝胶中阿魏酸含量的高效液相色谱法并考察制剂的稳定性。方法色谱柱为月旭Ultimate Plus⁃C_(18)柱(4.6 mm×250 mm,5μm);流动相为甲醇⁃0.1%醋酸溶液,梯度洗脱;检测波长为324 nm;流速为1.0 mL·min^(-1);柱温为35℃;进样量为20μL。制剂稳定性通过加速试验和长期试验进行考察。结果阿魏酸在0.6687~33.4357μg·mL^(-1)(r^(2)=1.0000)范围内线性关系良好,平均回收率101.42%。制剂稳定性考察结果符合质量要求。结论所建方法快速,准确,重复性好,可用于正骨消肿止痛凝胶的质量控制且该制剂稳定性良好。OBJECTIVE To develop a HPLC method for the determination of ferulic acid in ZhengGu Xi⁃aoZhong Zhitong gel and investigate the stability of the preparation.METHODS A Welch Ultimate Plus⁃C_(18) column(4.6 mm×250 mm,5μm)was used with methanol-0.1%acetic acid solution as mobile phase by gradient elu⁃tion.The flow rate was 1.0 mL·min^(⁃1),and the column temperature was 35℃.The detection wavelength was 324 nm and the injection volume was 20μL.In addition,the stability of the preparation was investigated through accelerated testing and long⁃term testing.RESULTS The linear relationship of ferulic acid was good within the range of 0.6687⁃33.4357μg·mL^(-1)(r^(2)=1.0000).The average recovery rate was 101.42%.The stability investigation re⁃sults of the preparation met the quality requirements.CONCLUSION This method was rapid,highly accurate,pre⁃cise and reproducable,which can be used for the quality control of ZhengGu XiaoZhong ZhiTong gel and the prepara⁃tion had a good stability.

关 键 词：高效液相色谱法 正骨消肿止痛凝胶 阿魏酸 稳定性 

分 类 号：R927[医药卫生—药学]