Simultaneous determination of zidebactam and cefepime in dog plasma by LC-MS/MS and its application to pre-clinical pharmacokinetic study.

A precise and accurate liquid chromatography-tandem mass spectrometric (LC-MS/MS) bioanalytical method has been developed and validated for the simultaneous quantification of zidebactam (ZID) and cefepime (FEP) in dog plasma. Ceftazidime was used as an internal standard. Protein precipitation method was used as sample preparation approach. The calibration curve obtained was linear (r ≥ 0.99) over the concentration range 0.156-80 µg/mL for ZID and 0.312-160 µg/mL for FEP. The method was validated as per US Food and Drug Administration guidelines and the results met the acceptance criteria. A run time of 3.5 min for each sample made it possible to analyze the maximum number of samples per day. The proposed method was successfully applied for pharmacokinetic study in beagle dogs.

Application of UV spectrophotometric method for easy and rapid estimation of lafutidine in bulk and pharmaceutical formulation.

INTRODUCTION: The present research work discusses the development of a UV estimation method for lafutidine. Simple, accurate, cost efficient, and reproducible spectrophotometric method has been developed for the estimation of Lafutidine in bulk and pharmaceutical dosage form. MATERIALS AND METHODS: The Stock solution was prepared in a mixture of water and methanol (1:1). Further dilutions were made in water. RESULTS: The drug was determined at maximum wavelength (λmax) 279 nm. Beers law was obeyed in the concentration range of 10-50 µg/ml having line equation y = 0.0100x + 0.035 with correlation coefficient of 0.999. Results of the analysis were validated statistically and by recovery study. CONCLUSION: The result of analysis was validated as per ICH guidelines and this method can be used for the routine analysis of lafutidine formulation.