Analysis of the salt-forming rate of two components in amoxicillin sodium and clavulanate potassium for injection
Objective This research established an ion chromatographic method for simultaneous determination of sodium and potassium ions in amoxicillin sodium and clavulanate potassium for injection.According to the salt-forming rate,the salt-forming processes of different enterprises were evaluated.Methods A cation exchange chromatography column of IonPac CS-12A(4 mm×250 mm)and a protection column of IonPac CG-12A(4 mm×50 mm)were used.The detector was a suppressed conductivity detector,and the suppressor current was 20 mA.An isocratic eluent of 6.7 mmol/L of methane sulfonic acid(MSA)solution was chosen as the mobile phase,with a flow rate of 1.0 mL/min.Results The linear correlation of sodium ions was good within the range of 6.01～18.04 μg/mL(r=0.9999,n=5).The average recovery was 100.4％(RSD=0.4％,n=9).The linear correlation of potassium ions was good within the range of 3.33～9.98 μg/mL(r=0.9998,n=5).The average recovery was 100.2％(RSD=0.5％,n=9).The content of sodium and potassium ions in 37 batches of amoxicillin sodium and clavulanate potassium for injection were determined,with salt-forming rates ranging from 1.00 to 1.13 and 0.94 to 1.05,respectively.Conclusions This method could be used for the determination of sodium and potassium ions in amoxicillin sodium and clavulanate potassium for injection.The salt-forming rate of samples from various enterprises was promising,but attention should be paid to the residue of salt-forming agents.
Amoxicillin sodium and clavulanate potassium for injectionSalt-forming rateIon chromatographySodium ionsPotassium ions
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