Development and Validation of a Novel Reverse Phase HPLC for Determination of Aloperine in Aloperine Tablets  

反相高效液相法测定苦豆碱方法的建立与有效性验证及苦豆碱片的含量测定(英文)

作　　者：WANGHua ZHENGLi WANGZhan ZHANGYong-qiang] WUFeng-lan 

机构地区：[1]DepartmentofPharmaceutics,SchoolofPharmaceuticolSciences,PekingUnitersity,Beiting100083,China

出　　处：《Journal of Chinese Pharmaceutical Sciences》2003年第4期211-214,共4页中国药学（英文版）

摘　　要：Aim To develop a reverse phase HPLC method for the determination of aloperine, an alkaloid that is newly extracted from Sophora alopecuraides and has shown wide pharmacological effects including antibacterial and antiinflammatory actions. Methods The samples were analyzed on a ODS column with methanol water triethylamine (3∶97∶0 1 V/V) as a mobile phase. The flow rate was 1 0 mL·min -1 , and UV detection wavelength 205 nm. Results Linear regression equation was A=1 6920C+1 7455 (r 2=0 9999, n =5) in concentratins ranging from 20 to 120 μg·mL -1 . The recoveries were 101 2±1 46 % at 80 μg·mL -1 , 100 5±0 75% at 100 μg·mL -1 , and 100 7±1 10% at 120 μg·mL -1 , respectively, and the precisions of aloperine within or between run were from 0 80% to 1 98% ( n =5). The relative contents of aloperine in three lots of tablets were 101 59±1 38%, 98 46±0 23%, and 99 41±1 09% ( n =3). Conclusion The newly developed reverse phase HPLC method is simple and useful for daily assay of aloperine tablets and can overcome the interference from excipient and other alkaloids in titration and UV detection.Aim To develop a reverse phase HPLC method for the determination of aloperine, an alkaloid that is newly extracted from Sophora alopecuraides and has shown wide pharmacological effects including antibacterial and antimflammatory actions. Methods The samples were analyzed on a ODS column with methanol-water-triethylamine (3:97:0.1 V/V) as a mobile phase, The flow rate was 1.0 mL·min^-1, and UV detection wavelength 205 nm. Results Linear regression equation was A = 1.6920C + 1.7455 (r^2 = 0.9999, n = 5) in concentratim ranging from 20 to 120μg·mL^-1. The recoveries were 101.2±1.46 % at 80 μg·mL^-1, 100.5±0.75% at 100μg·mL^-1, and 100.7±1.10% at 120 μg·mL^-1, respectively, and the precisions of aloperine within or between run were from 0.80% to 1.98% ( n = 5). The relative contents of aloperine in three lots of tablets were 101.59 ± 1.38%, 98.46 ± 0.23%, and 99.41 ± 1.09% ( n = 3).Conclusion The newly developed reverse phase HPLC method is simple and useful for daily assay of aloperine tablets and can overcome the interference from excipient and other alkaloids in titration and UV detection.

关 键 词：ALOPERINE aloperine tablets RP HPLC 

分 类 号：R927.2[医药卫生—药学]