庆大霉素普鲁卡因维B_(12)颗粒中维生素B_(12)含量及含量均匀度研究

Determination of Content and Content Uniformity of Vitamin B_(12) in Gentamycin Sulfate,Procaine Hydrochloride and Vitamin B_(12) Granules

目的建立测定庆大霉素普鲁卡因维B_(12)颗粒中维生素B_(12)含量的高效液相色谱法,并研究其含量均匀度。方法色谱柱为Alltima C18柱(250 mm×4.6 mm,5μm),流动相为0.02 mol/L磷酸二氢钠-甲醇(80∶20,V/V),流速为1.0 m L/min,检测波长为361 nm,柱温为35℃,进样量为50μL。结果维生素B_(12)质量浓度在0.01~0.30μg/m L范围内与峰面积线性关系良好(r=0.9999,n=5);精密度、稳定性、重复性试验的RSD均小于2.0%(n=6),平均加样回收率为98.53%,RSD为0.70%(n=6)。3批样品中维生素B_(12)含量平均值分别为99.81%,98.73%,99.84%,A+2.2 S分别为4.12,5.08,6.41。结论该方法简便、准确,专属性强,重复性好,可用于庆大霉素普鲁卡因维B_(12)颗粒中维生素B_(12)的含量及含量均匀度研究。

Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of Vitamin B_(12) in Gentamycin Sulfate,Procaine Hydrochloride and Vitamin B_(12) Granules and to study their content uniformity.Methods The chromatographic column was Alltima C18 column(250 mm×4.6 mm,5μm),the mobile phase was 0.02 mol/L sodium dihydrogen phosphate-methanol(80∶20,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 361 nm,the column temperature was 35℃,and the injection volume was 50μL.Results The mass concentration of vitamin B_(12) showed a good linear relationship with peak area in the range of 0.01-0.30μg/m L(r=0.9999,n=5).The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6),the average recovery of vitamin B_(12) was 98.53%with the RSD of 0.70%(n=6).The average contents of vitamin B_(12) in the three batches of samples were 99.81%,98.73%and 99.84%,respectively,and the contents of A+2.2 S were 4.12,5.08 and 6.41,respectively.Conclusion The method is simple,accurate,specific and reproducible,which can be used to determine the content and content uniformity of vitamin B_(12) in Gentamycin Sulfate,Procaine Hydrochloride and Vitamin B_(12) Granules.