摘要
目的研究注射用复合维生素冻干粉针中水溶性维生素的提取方法,分别建立该制剂中6种水溶性维生素和4种脂溶性维生素含量测定的反相高效液相色谱法。方法水溶性维生素含量测定采用DiamonsilTM C18色谱柱(4.6 mm×20 mm,5μm);流动相A为甲醇,流动相B为20 mmol·L-1磷酸二氢钾缓冲盐(磷酸调pH值4.0),梯度洗脱;流速1.0 mL·min-1;以214 nm和254 nm为检测波长,双波长检测。脂溶性维生素含量测定采用Tigerkin C18色谱柱(4.6 mm×20 mm,5μm);流动相为甲醇-异丙醇(体积比95∶5);检测波长235 nm;流速1.0 mL·min-1。结果各种维生素含量测定方法的线性关系良好,相关系数为0.999 6～1.000,回收率98.1%～101.9%,RSD为0.5%～1.9%。结论实现了对亚微乳剂中水溶性维生素的提取分离,含量测定方法简单快速,精密度好,结果准确可靠。
Objective To establish the extraction method for water-soluble vitamins and RP-HPLC methods for determination of vitamins in drug.Methods Water-soluble vitamins were determined on DiamonsilTM C18 column（4.6 mm×20 mm,5 μm）,using the mobile phase of A（methanol）and B（20 mmol · L-1 potassium dihydrogen phosphate buffer,pH adjusted to 4 by phosphoric acid）,gradient elution,at a flow rate of 1.0 mL · min-1,with dual wavelength detection in 214 nm and 254 nm.Oil-soluble vitamins were determined on Tigerkin C18 column（4.6 mm×20 mm,5 μm）,using methanol-isopropanol（V∶ V=95∶ 5）as mobile phase,at a flow rate of 1.0 mL · min-1 and detected at 235 nm.Results The linear relation of vitamins had a good regression coefficient and the average recovery rate were between 98.1%-101.9%.Conclusions The methods for the extraction and separation of water-soluble vitamins from the drug are established.The determination method is proved to be simple,rapid,accurate and reliable.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2011年第6期442-447,452,共7页
Journal of Shenyang Pharmaceutical University
