Development and Validation of Stability Indicating Method for Simultaneous Estimation of Ceftriaxone and Sulbactam Injection using RP-UPLC Method

Abstract

This research manuscript describes simple, sensitive, accurate, precise and repeatable RP- UPLC method for the simultaneous determination of Ceftazidime (CTZ) and Tazobactam (TAZ) Injection in combine dosage form. The sample was analyzed by reverse phase C18 column (Acquity UPLC BEH 100 × 2.1 mm ID, 1.7 µm) with mobile phase. In mobile phase, Solution A containing Potassium Dihydrogen Phosphate buffer (pH adjusted to 6.5±0.2 with Orthophosphoric acid), Citric acid buffer (pH adjusted to 5.0±0.2 with NaoH solution) and Acetonitrile and Solution B containing Tetradecyl ammonium bromide, Tetraheptyl ammonium bromide and Acetonitrile in the flow rate of 0.3 ml/min. Quantification was achieved 230 nm with PDA detector. The retention time for Ceftazidime and Tazobactam was found to be 1.02 and 1.69 minute respectively. The linearity for Ceftazidime and Tazobactam was obtained in the concentration range of 40280 µg/ml and 5-35 µg/ml respectively. Ceftazidime and Tazobactam API and market formulation were subjected to acid and alkali hydrolysis, oxidation, thermal and photolytic forced degradation. The peak purity of drug substance and drug product peak also confirmed the specificity of the methods with respect to the degradation products. In the forced degradation study Ceftazidime and Tazobactam showed maximum degradation in base hydrolysis stress study followed by less degradation in thermal degradation. The developed method was simple, specific, sensitive, rapid, and economic and can be used for estimation of Ceftazidime and Tazobactam in bulk and their combined dosage form for routine analysis W