Determination of Glycolic Acid and Lactic Acid in Leuprorelin Acetate Sustained-release Microspheres by HPLC
An HPLC method was established to simultaneously determine the contents of glycolic acid and lactic acid in leuprorelin acetate sustained-release microspheres.The Waters XSelect HSS T3 column(4.6 mm× 100 mm,3.5 μm)was used,and the analysis was carried out in the gradient elution mode with the mixed solution of phosphoric acid and water as mobile phase A,and acetonitrile as mobile phase B.The detection wavelength was 210 nm,the flow rate was 1.0 mL/min,the column temperature was 40 ℃,and the injection amount was 5 μL.The results showed that the method had good specificity,and it was linear for glycolic acid and lactic acid in the ranges of 0.015-0.06 mg/mL.The detection limits for both glycolic acid and lactic acid were 0.008 mg/mL,and the quantification limits were 0.03 mg/mL.The average recovery rates of glycolic acid and lactic acid were 99.2％and 101.6％,respectively,with the RSDs were 1.54％and 1.37％,respectively.The results indicated that this method could be used for the determination of glycolic acid and lactic acid content in leuprorelin acetate sustained-release microspheres and their degradation process.
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