摘要
建立了高效液相色谱法测定生物素的有关物质.采用C18色谱柱,以16.7 mmol/L磷酸盐缓冲液(pH 2.9)∶甲醇为流动相,梯度洗脱,检测波长210 nm.在上述色谱条件下生物素与各中间体及降解产物均能有效分离,4种己知有关物质在1~20 μg/ml范围内线性关系良好,平均回收率为93.3%~99.3%,最低检测限分别为0.365、0.280、0.255和0.480 μg/ml.
An HPLC method was established for the determination of the related substances in biotin.A C18 column was used,with the mobile phase of PBS (16.7 mmol/L,pH 2.9):methanol by gradient elution,at the detection wavelength of 210 nm.Biotin and the related substances were well separated.The calibration curves for related substances A-D were linear in the range of 1-20 μg/ml.Their average recoveries were 93.3 %-99.3 %,and the low limits of detection were 0.365,0.280,0.255 and 0.480 μg/ml,respectively.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2014年第11期1066-1069,共4页
Chinese Journal of Pharmaceuticals