Determination Related Substances and Content of Repaglinide by RP-HPLC
Objective To analyze the content of repaglinide and its related substances by RP-HPLC.Methods J&K WpHC18 column(4.6 mm×250 mm,5 μm)was used with 0.1%formic acid solution-methanol(32∶68)as mobile phase,flow rate was 1.0 mL/min,detection wavelength was 243 nm,column temperature was 20℃,and sample size was 20 μL.Results The linear correlation of repaglinide was good in the range of 10.06-80.72 μg/mL(Y=0.012 1X+0.010 7,r=0.999 7),RSD of repeatability test was 1.01%(n=6),recovery was 99.2%,detection limit was 4.0 ng,and quantitation limit was 11.5 ng.The average content of repaglinide by external standard method was 99.6%.The main peak and other impurity peaks were obviously different.The content of related substances in three batches of repaglinide samples were 0.17%,0.14%and 0.15%,respectively.Conclusion RP-HPLC method is convenient,specific,highly precise and reliable,and can be used for the determination of repaglinide.
万方数据
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