Analytical Method Development and Validation for the Simultaneous Estimation of Ceftolozane and Tazobactam in Its Bulk and Pharmaceutical Dosage Forms

Dr. K. Nageswara Rao^1*, Raghava Doonaboyina², R. Mahesh Babu^3
1Professor and Head, Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
²Associate Professor and Head, Department of Pharmaceutical Chemistry, K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.
³K.G.R.L College of Pharmacy, KGRL Road, Bhimavaram, West Godavari, Andhra Pradesh, India.

A B S T R A C T
A new method was established for simultaneous estimation of Tazobactam and Ceftolozane by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tazobactam and Ceftolozane by using AgilentC18 column (4.6×250mm)5µ, flow rate was 1ml/min, mobile phase ratio was (75:20 v/v) Methanol: phosphate buffer(KH₂PO₄and K₂HPO₄)phosphate pH 3 ( pH was adjusted with orthophosphoricacid), detection wavelength was 234 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Tazobactam and Ceftolozane was found in concentration range of 305µg-150µg and 4µg-8µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 99.9% and 100.0%, %RSD for repeatability was 1.5 and 0.1, % RSD for intermediate precision was 0.6 and 0.5 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 2.93 and 2.97 and LOQ value was 9.90 and 9.90 respectively.
Keywords: Tazobactam, Ceftolozane, RP-HPLC, Methanol.