RP-HPLC同时测定沙那制剂不同剂型中没食子酸等5种活性成分含量  

Simultaneous determination of five active ingredients including gallic acid in different dosage forms of Sana preparation by reverse-phase high-performance liquid chromatography

作　　者：艾比拜·尼牙孜 迪力穆拉提·买买吐逊 希尔艾力·吐尔逊 李建梅 Aibibai Niyazi;Dlimulati Maimaitusun;Xirali Tursun;Li Jianmei(College of Food Science and Pharmacy,Xinjiang Agricultural University,Urumqi 830052,Xinjiang Uygur Autonomous Region,China;Standards Research Office,Xinjiang Uygur Autonomous Region Key Laboratory of Traditional Uygur Medicine,Urumqi 830049,Xinjiang Uygur Autonomous Region,China;School of Traditional Uygur Medicine,Xinjiang Medical University,Urumqi 107600,China)

机构地区：[1]新疆农业大学食品科学与药学学院,乌鲁木齐830052 [2]新疆维吾尔自治区维吾尔医药研究所标准研究室,乌鲁木齐830049 [3]新疆医科大学维吾尔医学院,乌鲁木齐107600

出　　处：《中国基层医药》2023年第5期735-740,共6页Chinese Journal of Primary Medicine and Pharmacy

基　　金：新疆维吾尔自治区公益性科研院所项目(ky2021060);新疆维吾尔自治区地产中药民族药新药研发项目(Q2015=02-04)。

摘　　要：目的建立反相高效液相色谱法(RP-HPLC)同时测定沙那制剂中没食子酸、没食子酸甲酯、柯里拉京、番泻苷B和番泻苷A含量的方法。方法2021年1-12月,采用Phenomenex Hydro-RP 80A色谱柱(4.60 mm×250 mm,4μm),流动相为甲醇(A)-0.2%甲酸(B),梯度洗脱:0~18 min,1%~3%A;18~19 min,3%~15%A;19~40 min,15%~17%A;40~45 min,17%~25%A;45~65 min,25%~35%A;65~95 min,35%~60%A;95~96 min,60%~90%A;96~97 min;90%~1%A,流速:1.0 mL/min,柱温:35℃,检测波长270 nm。结果没食子酸、没食子酸甲酯、柯里拉京、番泻苷B和番泻苷A的线性范围分别为0.182~1.099µg(r=0.9999),0.046~0.278µg(r=0.9992),0.266~1.598µg(r=0.9994),0.172~1.036µg(r=0.9992),0.176~1.056µg(r=0.9999);平均加样回收率分别为100.02%、99.14%、99.38%、101.77%、100.92%。结论该方法准确、灵敏、可靠、重复性好,可用于沙那制剂的质量控制研究。Objective To establish reverse-phase high-performance liquid chromatography and simultaneously determine gallic acid,methyl gallate,corilagin,Sennoside B,and Sennoside A levels in Sana preparations.Methods From January to December 2021,Phenomenex Hydro-RP 80A column(4.60 mm×250 mm,4μm)was used.Elution was conducted using mobile phases methanol(A)-0.2%formic acid(B).The following gradients were applied:1%-3%A for 0-18 minutes,3%-15%A for 18-19 minutes,15%-17%A for 19-40 minutes,17%-25%A for 40-45 minutes,25%-35%A for 45-65 minutes,35%-60%A for 65-95 minutes,60%-90%A for 95-96 minutes,90%-1%A for 96-97 minutes.The flow rate was 1.0 mL/minute.The column temperature was 35℃.The detection wavelength was 270 nm.Results The linear ranges of gallic acid,methyl gallate,corilagin,Sennoside B and Sennoside A were 0.182-1.099μg(r=0.9999),0.046-0.278μg(r=0.9992),0.266-1.598μg(r=0.9994),0.172-1.036μg(r=0.9992),and 0.176-1.056μg(r=0.9999).The average dosing recovery rates were 100.02%,99.14%,99.38%,101.77%,and 100.92%,respectively.Conclusion Reverse-phase high-performance liquid chromatography can be used for quality control of Sana preparations because of high accuracy,sensitivity,reliability,and reproduction.

关 键 词：色谱法 高效液相 沙那制剂 番泻苷A、B 没食子酸 制剂工艺 

分 类 号：O657.72[理学—分析化学] R927.1[理学—化学]