HPLC determination of related substances in olaparib raw materials
Objective:To establish an HPLC method for the determination of related substances in olaparib raw materials.Methods:By using YMC-Pack pro C18 AS(150 mm × 4.6 mm,3 μm)column,0.05 mol·L-1 potassium dihydrogen phosphate(pH 3.0 adjusted with dilute phosphoric acid)-methanol-acetonitrile(90∶5∶5)was as mobile phase A and methanol-acetonitrile-water(45∶45∶10)was as mobile phase B,in gradient elution,with flow rate of 0.8 mL·min-1.The column temperature was 30 ℃,the detection wavelength was 210 nm,and the injection volume was 10 μL.Results:The solvent blank did not interfere with the determi-nation of relevant substances in the test solution,the known impurities Ⅰ-Ⅶ and unknown impurities in the system suitability solution were well separated in the chromatographic system.Olaparib had a good linear relationship with its peak area in the concentration range of 0.083-333.133 μg·mL-1.The concentrations of impurities Ⅰ-Ⅶ were 0.05-3.0 pg·mL-1,there were good linear relationships with their peak area,and their r were 0.999 7 or above.The average recoveries of impurities Ⅰ-Ⅶ were all above 92.0％,and RSDs were less than 4.0％.Conclusion:The HPLC method for the detection of the related substances of olaparib raw materials has strong specificity,high sensitivity,high accuracy and good precision,which can meet the require-ments for the detection of related substances of olaparib raw materials.
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