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目的 苦豆碱是从宁夏产药用植物苦豆子中提取出来的一类新药 ,目前尚无合适的检测方法用于苦豆碱片的含量测定。由于辅料的干扰 ,用于测定纯苦豆碱的紫外分光光度法不能用于片剂的含量测定。本文拟建立反相高效液相紫外色谱法测定苦豆碱片中苦豆碱的含量。方法 色谱条件 :ODS柱 ,流动相为甲醇 -水 -三乙胺 ( 3∶97∶0 1V V) ,流速 1 0mL·min- 1 ,检测波长为 2 0 5nm。结果 在 2 0～ 12 0 μg·mL- 1 浓度范围内 ,回归方程为A =1 6 92 0C + 1 74 5 5 (r2 =0 9999,n =5 )。80 ,10 0及 12 0 μg·mL- 1 三种浓度的回收率分别为 10 1 2± 1 4 4 % ,10 0 5± 0 75 %和 10 0 7± 1 10 % (n =3) ,相应的日内及日间精密度为 0 80～ 1 98%。三批样品的相对标示百分含量为 10 1 5 9± 1 38% ,98.4 6± 0 2 3%and 99.4 1± 1 0 9% (n =3)。结论苦豆碱高效液相色谱法的建立 ,排除了辅料对苦豆碱含量测定时的干扰 ,为一类新药苦豆碱片的质量控制提供了一种新的、有效的方法。
Objective Aloperine is a new type of drug extracted from the medicinal plant Prunus persicae in Ningxia. At present, there is no suitable detection method for the determination of the content of abrinine tablets. Due to the interference of excipients, UV spectrophotometry for the determination of pure abrinine cannot be used for the determination of tablets. This article intends to establish a reversed-phase high performance liquid chromatography (UHPLC) method for the determination of aloperine in abrinin tablets. Methods Chromatographic conditions: ODS column, mobile phase methanol-water-triethylamine (3∶97:0 1VV), flow rate 10 mL·min-1, detection wavelength at 20 nm. Results Within the range of 2 0 ~ 12 0 μg·mL - 1 , the regression equation was A =1 6 92 0C + 1 74 5 5 (r2 = 0 9999, n = 5). The recoveries of three concentrations of 80, 100, and 120 μg·mL-1 were 1012±14%, 100.5±0.75%, and 100.7±10% (n=3), respectively. The corresponding intraday and inter-day precision is 0 80 to 1980%. The relative labeling percentages of the three batches of samples were 10159±138%, 98.4 6±02.3%, and 99.4 1±109% (n=3). Conclusion The establishment of HPLC for Aloperin prevented the interference of excipients in the determination of abrinine content, providing a new and effective method for the quality control of a new class of drug Somatotropin tablets.