摘要
目的 建立通塞益脑口服液中α-细辛醚和β-细辛醚的含量测定方法,为生产质量提供保障。方法 采用高效液相色谱法测定,色谱柱为Lichrospher-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.05%磷酸溶液(54∶46),流速为1.0 m L/min,柱温为30℃,检测波长为257 nm。结果α-细辛醚在1.248~6.240μg/m L范围内有良好的线性关系,Y=85 526X-1.0581(r=0.9999),β-细辛醚在2.632~13.159 mg/m L范围内有良好的线性关系,Y=41727X-0.0433(r=0.9999),平均回收率分别为99.07%、101.94%,RSD分别为2.15%、2.83%(n=6)。结论 该方法准确易行,便于通塞盖脑口服液的质量控制。
Objective To establish a method for the determination of ct-asarone and [5-asarone in Tongsaiyinao Oral liquid, and protect the production of quality. Methods The determination was performed by HPLC method, the chro- matographic colum was Lichrospher-Cls column (250 mm×4.6 mm,5 μm), the mobile phase was methanol-0.05% H3PO4 (54:46), the flow rate was 1.0 mL/min and the temperature of column was 30℃ with the detection wavelength of 257 nm. Results The linear correlation of ct-asarone was 1.248-6.240 txg/mL, Y = 85 526X-1.0581, r = 0.9999, and the average recovery was 99.07%, RSD was 2.15% (n = 6). The linear correlation of β-asarone was 2.632-13.159 μg/ mL, Y = 41 727X-0.0433, r = 0.9999, and the average recovery was 101.94%, RSD was 2.83% (n = 6). Conclusion The HPLC method is accurate and feasible. It can be used very convenient in quality control.
出处
《中国医药导报》
CAS
2015年第21期4-7,共4页
China Medical Herald
基金
全军医疗机构制剂标准提高科研专项课题(13ZJZ15-2)