高效液相色谱法测定醋酸泼尼松片中相关物质含量

目的:探讨高效液相色谱法测定醋酸泼尼松片中相关物质含量。方法:采用ZORBAX SB C18(规格:4.6 mm×250 mm,5μm)色谱柱,流动相为甲醇-水(58∶42),流速为1.0 mL.min-1,柱温30℃,检测波长为240 nm,进样量取10μL。结果:醋酸泼尼松、泼尼松、醋酸可的松在浓度范围0.52～30.81μg.mL-1之间有良好的线性关系,平均回收率(n=6)为99.36%,RSD=1.31%。结论:本研究方法专属性强、重复性好、结果准确,为醋酸泼尼松片中醋酸泼尼松、泼尼松、醋酸可的松含量测定提供了科学、专属的方法。

Determination of The Contents of The Related Substances in Prednisone Acetate Tablets by HPLC

OBJECTIVE: To determination the contents of the related substances in Prednisone Acetate Tablets by HPLC.METHDOS: The determination was performed by using chromatographic column ZORBAX SB C18(4.6 mm×250 mm,5 μm) with mobile phase consisted of methanol-water(58∶42) at a flow rate of 1.0 mL with column temperature kept at 30 ℃,detecting wavelength was set at 240 nm.The sample size was 10 μL.RESULTS: The linear range of prednisone acetate,metacortandracin and cortisone acetate stood at 0.52-30.81 μg·mL-1.The average recovery rate was 99.36%(n=6,RSD=1.31%).CONCLUSION: This method established in this study was proved to be specific,reproducible,and accurate in results and it serves as a scientific and specific method for determination of prednisone acetate,metacortandracin and cortisone acetate in Prednisone Acetate Tablets.