Development And Validation of A Stability-Indicating UHPLC Method For Simultaneous Estimation of Cefoperazone And Sulbactam in Powder For Injection Dosage Form

Abstract

Background:Cefoperazoneand sulbactam arecommonly combined in pharmaceutical preparations, requiringreliableanalyticalmethodsforsimultaneousestimationandqualitycontrol.Objectives:The present study aimed to develop and validate a rapid and reliable ultra-highperformance liquid chromatography (UHPLC) method for simultaneous estimation of cefoperazone and sulbactam in powder for injection dosage form. Materials and Methods:Chromatographic separation was achieved using a C18 column(50 mm × 2 mm, 4 µm) under isocratic conditions. The mobile phase consisted of 10 mM phosphate buffer adjusted to pH 3.2 with orthophosphoric acid and acetonitrile in the ratio of 84:16 (v/v). The flow rate was 0.5 mL/min, injection volume was 2 µL, detection wavelength was 230 nm and total run time was 5 min. The method was evaluated for system suitability, specificity, assay, linearity, precision, accuracy and robustness. Results:Cefoperazoneandsulbactamshowedretentiontimesofapproximately2.452and1.132min, respectively. The assay results were 99.73% for cefoperazone and 100.51% for sulbactam. The method demonstrated excellent linearity with correlation coefficients (R²) of 0.9999 and 0.9995 for cefoperazoneandsulbactam,respectively.Repeatability%RSDvalueswere0.12%and0.25%,while intermediate precision values were 0.23% and 0.33%, respectively. Accuracy results ranged from 99.29–100.47%forcefoperazoneand99.84–100.97%forsulbactam.Robustnessstudiesshowed % RSDvaluesbelow2%. Conclusion: The developed UHPLC method was found to be rapid, precise, accurate and robust for simultaneousestimationofcefoperazoneandsulbactaminpowderforinjectiondosageformandmay be suitable for routine pharmaceutical quality-control analysis.