Determination of the contents and related substances of Cefriaxone sodium / Tazobactam sodium for injection by HPLC

OBJECTIVE To establish an HPLC method for the determination of the contents and related substances of Cefriaxone sodium / Tazobactam sodium for injection. METHODS An Kromasil C18column( 250 mm × 4. 6 mm,5 μm) was used. The mobile phase was phosphate buffer solution- acetonitrile( 90∶10). The flow rate was 1. 0 m L·min- 1,the column temperature was 30 ℃ and the detection wavelength was 230 nm. RESULTS In terms of contents,the caliblation curve for Tazobactam was linear in the range of0. 05 to 0. 40 mg·m L- 1( r = 0. 9999). The RSD of repeatability was 1. 5%; the average recovery was 101. 0% and the quantitative limit was 0. 12 μg. The caliblation curve for Ceftriaxone was linear in the range of 0. 15 to 1. 20 mg·m L- 1( r = 0. 9999). The RSD of precision was 0. 5%,the average recovery was 100. 9% and the quantitative limit was 0. 04 μg. In terms of related substances,the caliblation curve for Tazobactam was linear in the range of 2. 5 to 25. 3 μg·m L- 1( r = 0. 9999). The RSD of precision was 2. 0% and the detection limit was 0. 04 μg. The caliblation curve for Cefriaxone was linear in the range of 7. 5 to 75. 0 μg·m L- 1( r = 0. 9999). The RSD of precision was 0. 5% and the detection limit was 0. 01 μg. Every two peaks of each impurity with Ceftriaxone and Tazobactam could be completely separated. CONCLUSION Through the methodology validation,the method is a new reliable analytical method for the quality control of Cefriaxone sodium / Tazobactam sodium for injection.