摘要
目的:建立测定叶酸片的溶出度UPLC方法。方法:采用外标法,选择Waters BEH RP18(2.1×100 mm 1.7μm)为固定相,甲醇-0.1%磷酸(用氨水调pH至6.0)(15︰85)为流动相,流速0.4 mL·min^(-1),检测波长为280 nm,柱温40℃。结果:叶酸在浓度0.04~1.0μg·ml^(-1)范围内线性关系良好。叶酸平均回收率为99.7%。测得3批叶酸片平均溶出度为99.8%、100.1%和100.4%。结论:该方法专属性强、灵敏度高、操作简单,可用于测定叶酸片的溶出度。
Objective: To establish a UPLC method for determination of dissolution in folic acid tablets. Methods: The external standard method. The analysis was performed on a Waters BEH RP18 (2.1×100 mm 1.7 μm). The mobile phase was composed of methyl alcohol and 0.1% phosphoric acid (pH=6.0 with ammonium hydroxide)with the volume ratio of 15 : 85. The flow rate of mobile phase and the detection wavelength and the column temperature were 0.4 mL-min-1 and 280 nm and 40 ℃, respectively. Results: The chromatographic perk area and concentration of folic acid showed a good linear relationship at the range of 0.04-1.0 μg·mL-1. The average recovery of folic acid was 99.7 %. Three batches of samples average dissolution was 99.8 %, 100.1% and 100.4 %. Conclusion:The method is specific,sensitive and simple operation.lt can be used tbr determination of dissolution in folic acid tablets.
出处
《广东化工》
CAS
2017年第23期113-114,共2页
Guangdong Chemical Industry
关键词
叶酸片
溶出度
超高效液相色谱法
folic acid tablets
determination ofdissolution
UPLC method