Determination of isomeric impurity β-propranolol content in propranolol hydrochloride by HPLC
Objective To determine the content of isomeric impurity β-propranolol in propranolol hydrochloride by HPLC.Methods YMC-Pack ODS-AQ(150 mm × 4.6 mm,3 μm)chromatographic column was used.Mobile phase A was lauryl sodium sulfate and four butyl ammonium dihydrogen phosphate solution-acetonitrile(70∶30),while mobile phase B was lauryl sodium sulfate and four butyl ammonium dihydrogen phosphate solution-acetonitrile(30∶70).The online isocratic elution A-B(70∶30)was used,the flow rate was 0.8 mL·min-1,the detection wavelength was 225 nm,and the injection volume was 20 μL.Results The limit of detection of β-propranolol was 0.1 ng and the limit of quantification was 0.3 ng;β-propranolol showed good linearity within 0.015～1.981 μg·mL-1(r=0.9999);the average recovery at low,medium,and high concentration levels was 99.06％,100.4％,and 100.5％,while the RSD was 0.18％,0.10％,and 0.060％(n=3).Conclusion This method is simple,sensitive,acurate and reliable,which provides reference for the quality control of β-propranolol in propranolol hydrochloride.
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