Thursday , 11 July 2024

A new RP-HPLC Stability Indicating Method Developed and Validated for the Simultaneous Estimation of Ceftolozane and Tazobactum in Pharmaceutical Dosage Form

P.V. Guru Charan*, K.N. Maneesha, M. Sreenivasulu, Y. Prapurna Chandra
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur (V&P), Muthukur (M), SPSR Nellore District – 524 346

Abstract
The aim of this study is to develop and validate a new RP-HPLC method for the Simultaneous Estimation of Ceftolozane and Tazobactum in Pharmaceutical Dosage Form. The estimation of Tazobactum and Ceftolozone was done by RP-HPLC. The assay of Tazobactum and Ceftolozone was performed with tablets and the % assay was found to be 99.72 and 99.80 which shows that the method is useful for routine analysis. The linearity of Tazobactum and Ceftolozone was found to be linear with a correlation coefficient of 0.999 and 0.999, which shows that the method is capable of producing good sensitivity. The acceptance criteria of precision is RSD should be not more than 2.0% and the method show  precision 0.60 and 0.30 for Tazobactum and Ceftolozone which shows that the method is precise. The acceptance criteria for LOD and LOQ is 3 and 10. The LOD and LOQ for Tazobactum was found to be 3.02 and 10.00 and LOD and LOQ for Ceftolozone was found to be 3.00and 9.98. The robustness limit for mobile phase variation and flow rate variation are well within the limit, which shows that the method is having good system suitability and precision under given set of conditions.
Keywords: Ceftolozane, Tazobactum, LOD and LOQ, RP-HPLC, robustness

 

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