高效毛细管电泳法测定注射用水溶性维生素的含量

 目的采用高效毛细管电泳法(HPCE)的胶束毛细管色谱(MECC)模式分离和测定注射用水溶性维生素的含量。方法未涂层熔融石英毛细管67 cm(有效长度55 cm)×50μm;运行缓冲液为50 mmol·L^-1 SDS-50 mmol·L^-1的硼酸钠溶液(pH8.33);6.89 KPa×10 s压力进样;运行电压15.0 kV;检测波长214 nm;毛细管柱温25℃。结果注射用水溶性维生素中的九种成分分离完全,烟酰氨、维生素B6、D-生物素、核黄素磷酸钠、维生素B12、维生素C、泛酸钠、叶酸、维生素B1的线性范围分别为4.16～520.0 mg·L^-1(r=0.999 1),0.40～50.0 mg·L^-1(r=0.999 7),0.42-52.0 mg·L^-1(r=0.999 3),0.40～50.0 mg·L^-1(r=0.998 2),0.39-49.0 mg·L^-1(r=0.999 6),8.00～1 000.0 mg·L^-1(r=0.992 0),0.83-104.0 mg·L^-1(r=0.999 5),0.42～53.0 mg·L^-1(r=0.999 0),0.41～51.0 mg·L^-1(r=0.999 8),n=5;精密度(RSD)分别为1.75%,1.04%,1.6%,2.84%,1.85%,3.26%,1.58%,2.5%,1.92%(n=5);最低检测质量浓度分别为0.60,0.16,0.24,0.23,0.21,0.45,0.41,0.20,0.18 mg·L^-1。结论采用HPCE测定注射用水溶性维生素的方法简便、结果可靠。

Determination of the Contents of Water-soluble Vitamin for Injection by HPLC

OBJECTIVE To determine the contents of Water-soluble Vitamin for Injection by HPCE.METHODS The separation was performed on a fused-silica capillary column:67 cm(efficiency length 55 cm×50 μm),The mobile phase consisted of 50 mmol·L^-1 SDS——50 mmol·L^-1 Na₂B₄O₇·10H₂O solution(pH=8.33) eletroinjection:6.89 KPa×10 s;with running voltage of 15 kV.The detection wavelength was 214 nm.The column temperature was 25 ℃.RESULTS The linear ranges(n=5) for the determination of nicotinamide,Vitamin B₆,D-biotin,Riboflavin 5′-phosphate sodium,Vitamin B₁₂,Vitamin C,D-pantothenic acid sodium salt,folic acid and Vitamin B₁ were 4.16～520.0 mg·L_-1(r=0.999 1),0.40～50.0 mg·L_-1(r=0.999 7),0.42～52.0 mg·L^-1(r=0.999 3),0.40～50.0 mg·L^-1(r=0.998 2),0.39～49.0 mg·L^-1(r=0.999 6),8.00～1 000.0 mg·L^-1(r=0.992 0),0.83～104.0 mg·L^-1(r=0.999 5),0.42～53.0 mg·L^-1(r=0.999 0),0.41～51.0 mg·L^-1(r=0.999 8),respectively.The precision was good(with RSDs of 1.75%,1.04%,1.6%,2.84%,1.85%,3.26%,1.58%,2.5% and 1.92%,respectively(n=5).The detection limits were 0.60,0.16,0.24,0.23,0.21,0.45,0.41,0.20 and 0.18 mg·L^-1,respectively.CONCLUSION The method of determining contents of water-soluble vitamin for injection by HPCE is easy to operate and the results of the determination are accurate.