孙文霞， 陈 勇
Determination of Contents and Related Substances in Voglibose Oral Fast Dissolving
Films by HPLC
Abstract:The paper is going to establish an HPLC for the determination of both contents and related substances of voglibose in voglibose oral fast dissolving films.Post-column derivatization fluorescence method was used in the experiment.The analysis was performed on a C18 column with 0045% sodium octanesulfonate phosphate buffer solution methanol（94∶6） as mobile phase.The effluents were detected by fluoescence detector with an excitation wave length of 350 nm,an emission wave length of 430 nm and a column temperature of 25 ℃.The flow rate of the fluorescent reagents was the same as that of the mobile phase.And the injection volume was 100 μL.The results show that the linear relationship between the voglibose concentration and peak area is good(R=0.9999) within the range of 25.0～50.0 μg/mL for voglibose.The average recovery rates are from 98.81% to 101.58% for three different levels of voglibose,RSD is from 0.99% to 1.27%.The quantitation limit and detection limit is 2 ng and 10 ng,respectively.This method is accurate,specific,and suitable for the quality control of voglibose oral fast dissolving films.
Key words:voglibose;oral fast dissolving films;content determination;related substances