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目的:建立安神补脑液中维生素B1的测定方法,并对产品中维生素B1的稳定性进行考察。方法:采用HPLC-ELSD法,色谱柱:Diamonsil C18(250 mm×4.6 mm,5μm);流动相:乙腈-0.013 mol/L乙酸铵(用醋酸调pH至5.2)(4∶96);流速为0.5 mL/min;蒸发光散射检测器漂移管温度为105℃。结果:维生素B1在0.0505~0.5050mg/mL浓度范围内具有良好的线性关系,r=0.9999,样品中其他成分不干扰测定。3批安神补脑液中维生素B1的含量合格,均在标示量的110%~90%范围内,符合规定。在3个月、6个月、12个月、24个月后含量均能符合相应的标准。结论:该方法简单、快速、准确,可用于安神补脑液中维生素B1的含量测定。
OBJECTIVE: To establish a method for determination of vitamin B1 in Anshen Bunao fluid and investigate the stability of vitamin B1 in the product. The mobile phase consisted of acetonitrile-0.013 mol / L ammonium acetate (adjusted to pH 5.2 with acetic acid) (4:96), and the mobile phase was Diamonsil C18 (250 mm × 4.6 mm, 0.5 mL / min; evaporative light scattering detector drift tube temperature of 105 ℃. Results: Vitamin B1 had a good linearity in the range of 0.0505 ~ 0.5050 mg / mL, r = 0.9999. The other components in the sample did not interfere with the determination. Three batches of sedative Bunao fluid in the content of vitamin B1 qualified, are marked amount of 110% to 90% range, in line with the provisions. In 3 months, 6 months, 12 months, 24 months after the content can meet the corresponding standards. Conclusion: The method is simple, rapid and accurate and can be used to determine the content of vitamin B1 in Anshen Bunao fluid.