Determination of Four Common Bacteriostatic Agents in Atropine Sulfate Eye Drops by HPLC
OBJECTIVE To determine the content of four common bacteriostatic agents(4-hydroxybenzoic acid,benzoic acid,benzyl alcohol,and benzoic acid)in atropine sulfate eye drops by RP-HPLC.METHODS The separation was performed on a C18 column(4.6 mm ×250 mm,5 μm)with isometric elution.The mobile phase was composed of 0.05 mol·L-1 potassium dihydrogen phosphate solution(containing 0.0025 mol·L-1 heptane sodium sulfonate,adjusting pH value to 5.0 with triethylamine)-acetonitrile(90:10);The flow rate was 1.0 mL·min-1.The column temperature was 30 ℃ and the detection wavelength was 225 nm.RESULTS Under the selected chro-matographic conditions,it could separate four common bacteriostatic agents from main drug and formulation excipients without interference.The repeatability and stability of the method were good.The excellent linear behaviors over the investigated concentration ranges were observed.CONCLUSION The method is specific and repeatable,and the results are stable,it can be used for the detection of four common bacteriostatic agents in atropine sulfate eye drops.