高效液相色谱法测定维生素C阴道缓释片有关物质及含量

Determination of Vitamin C Vaginal Sustained-release Tablets and its related substances by HPLC

目的:建立测定维生素C阴道缓释片有关物质及含量的高效液相色谱法。方法:色谱柱为Phenomenex C18柱(250mm×4.6mm,5μm),流动相为磷酸盐缓冲液,流速为0.8ml/min,检测波长为245nm,柱温为25℃,进样量为10μl。结果:3批样品中有关物质的平均含量为0.13%;维生素C检测浓度的线性范围为23.5～188.0μg/ml,r=1.0000(n=5),平均回收率为100.3%,RSD为0.80%。结论:本检测方法灵敏、快速、结果准确,可用于维生素C阴道缓释片的质量控制。

Objective： To establish a high performance liquid chromatagraph （HPLC） method for the determination of Vi tamin C Vaginal Sustained-release Tablets and its related substances. Methods： The chromatographic separation was performed on a Phenomenex C,s column （250 mm×4.6 mm, 5 μm） with a mobile phase of phosphate buffer solution at the flow rate of 0.8 ml/min, the detection wavelength was 245 nm, the column temperature was 25℃ and the sample size was 10 μl. Results： The average content for the related substances in three batches of samples was 0.13%. The linear range of Vitamin C was 23.5-188.0 μg/ml, r=-1.000 0 （n=5）. The average recovery was 100.3% with RSD of 0.80%. Conclusion： The method is sensitive, rapid and accurate, and is suitable for the quality control of Vitamin C Vaginal Sustained-release Tablets.