METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CEFTOLOZANE AND TAZOBACTAM BY RP-HPLC METHOD IN PURE AND PHARMACEUTICAL DOSAGE FORM
P. Jyothi Reddy*, Dr. N. Anjaneyulu
ABSTRACT
Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Ceftolozane and Tazobactam in pharmaceutical dosage form. Methods: Chromatogram was run through XTerra C18 (4.6 x 150mm, 5 μm particle size). Mobile phase containing Phosphate buffer and Acetonitril in the ratio of 55:45 was pumped through column at a flow rate of 1ml/min. Buffer used at pH 4.6. Temperature was maintained at Ambient. Optimized wavelength for Ceftolozane and Tazobactam was 260 nm. Results: Retention time of Ceftolozane and Tazobactam were found to be 2.28 min and 3.62 min. The % purity of Ceftolozane and Tazobactam was found to be 100.5% and 101.2% respectively. The system suitability parameters for Ceftolozane and Tazobactam such as theoretical plates and tailing factor were found to be 2589.3, 5419.7, 1.11 and 1.34. The resolution was found to be 8.0. The linearity study for Ceftolozane and Tazobactam correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.1% and 100.4%, %RSD for repeatability was 1.2 and 0.60, % RSD for intermediate precision was 1.48 and 0.82 respectively. The precision study was precise, robust and repeatable. LOD value was 0.63 and 0.09, and LOQ value was 1.88 and 0.26respectively. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Ceftolozane and Tazobactam in pharmaceutical dosage form.
Keywords: Ceftolozane, Tazobactam, RP?HPLC, Simultaneous estimation.
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