“DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR SIMULTANEOUS ESTIMATION OF CEFTRIAXONE AND TAZOBACTAM INJECTION USING RP-UPLC METHOD”
2.1 OBJECTIVE
To develop and Validate Stability Indicating Method for simultaneous estimation of Ceftriaxone and Tazobactam in their combined dosage form by RP-UPLC method in various stress condition like, alkaline, acidic, oxidative, thermal and photo degradation.
2.4 METHODOLOGY
2.4.1 Chromatographic Condition
Column Separation was achieved by using Acquity UPLC BEH C-18 (1.7 μm), 2.1 X 100 mm as stationary phase. Flow rate is 0.3 ml/min. Quantification was achieved of of Ceftriaxone and Tazobactam at 230 nm with PDA detector. Column Temperature at 25 ± 2°C temperature condition and 1 μl injection …show more content…
• The % RSD values for Ceftriaxone and Tazobactam were found to be < 2 %, which indicates that the proposed method is repeatable. The low % RSD values of repeatability of assay (0.258-0.210 %), inter day (0.080-0.345 % and 0.045-0.321 %) and intraday (0.055-0.136 % and 0.055-0.090 %) variations for Ceftriaxone and Tazobactam, respectively (Table 2.03), reveal that the proposed method is precise.
• LOD values for Ceftriaxone and Tazobactam were found to be 0.005 μg/ml and 0.125 μg/ml, respectively and LOQ values for Ceftriaxone and Tazobactam were found to be 0.017 μg/ml and 0.416 μg/ml, respectively (Table 2.03). The results of system suitability testing are given in (Table 2.04).
• Peak of Degraded products were not interfering with the main drug peak of Ceftriaxone and Tazobactam. Thus, these degradation products have not been identified. The results of Degradation of Ceftriaxone and Tazobactam in different conditions are given in (Table
2.1 OBJECTIVE
To develop and Validate Stability Indicating Method for simultaneous estimation of Ceftriaxone and Tazobactam in their combined dosage form by RP-UPLC method in various stress condition like, alkaline, acidic, oxidative, thermal and photo degradation.
2.4 METHODOLOGY
2.4.1 Chromatographic Condition
Column Separation was achieved by using Acquity UPLC BEH C-18 (1.7 μm), 2.1 X 100 mm as stationary phase. Flow rate is 0.3 ml/min. Quantification was achieved of of Ceftriaxone and Tazobactam at 230 nm with PDA detector. Column Temperature at 25 ± 2°C temperature condition and 1 μl injection …show more content…
• The % RSD values for Ceftriaxone and Tazobactam were found to be < 2 %, which indicates that the proposed method is repeatable. The low % RSD values of repeatability of assay (0.258-0.210 %), inter day (0.080-0.345 % and 0.045-0.321 %) and intraday (0.055-0.136 % and 0.055-0.090 %) variations for Ceftriaxone and Tazobactam, respectively (Table 2.03), reveal that the proposed method is precise.
• LOD values for Ceftriaxone and Tazobactam were found to be 0.005 μg/ml and 0.125 μg/ml, respectively and LOQ values for Ceftriaxone and Tazobactam were found to be 0.017 μg/ml and 0.416 μg/ml, respectively (Table 2.03). The results of system suitability testing are given in (Table 2.04).
• Peak of Degraded products were not interfering with the main drug peak of Ceftriaxone and Tazobactam. Thus, these degradation products have not been identified. The results of Degradation of Ceftriaxone and Tazobactam in different conditions are given in (Table