Abstract: OBJECTIVE To establish an ion chromatography method for determination of tartaric acid in kitasamycin tartrate for injection, through the correlation study of tartaric acid salt-forming rate with pH value and clarity, evaluated the rationality of the salt-forming rate. METHODS The chromatographic separation was performed on an IonPac AS19 anion exchange column(4.0 mm×250 mm, 7.5 μm) and IonPac AS19 guard column(4.0 mm×50 mm), using suppressed conductivity detector. An isocratic eluent of 20 mmol·L^-1 KOH was chosen as mobile phase, flow rate was 1.1 mL·min^-1. Binary mixture of kitasamycin and tartaric acid prepared in different mass rations was performed to explore the possible correlation between the salt-forming rate and pH value and clarity. RESULTS A good linear relationship was observed within the range of 1.0-50.0 μg·mL^-1(r=0.999 8, n=6). The limit of quantification was 1.0 μg·mL^-1. The average spiked recovery was 99.5% at three concentration levels with RSD of 1.6%(n=9). Ten batches of samples from 2 manufactures were tested using this validated method, the percentage content of tartaric acid was between 10.9%-11.4%, and no significant difference was found between the samples from 2 manufactures. The pH value were all around 4.2-4.3. The compatibility test showed that the clarity of sample solution could only be achieved when the percentage content of tartaric acid was between 8.8% and 16.1%, meanwhile the pH value was around 3.4-5.0 under this condition. CONCLUSION This method is accurate and reliable to determine the content of tartaric acid in kitasamycin tartrate for injection. The salt-forming rate of kitasamycin and tartaric acid in the samples of kitasamycin tartrate for injection is reasonable and qualified.