ISSN : 2663-2187

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF CEFTAZIDIME AND AVIBACTAM IN BULK DRUG AND FORMULATION

Main Article Content

Parag A. Pathade, Amol H. Jogdand*, Bhaskar O. Aher and Vinod A. Bairagi
» doi: 10.48047/AFJBS.6.13.2024. 343-361

Abstract

A precise and robust method was developed method for the estimation of Ceftazidime and Avibactamin bulk and pharmaceutical dosage form.The Method used Agilent 1260 Infinity II model HPLC with DAD detector and Agilent Zorbax Bonus RP Column with dimension 250 x 4.6 mm, 5 m. The Mobile phase combination used was 0.1% Perchloric acid and Acetonitrile (80:20). Flow rate at 0.5 ml/min and wavelength at 230 nm with run time of 20 minutes. The retention time of Ceftazidime (CEF) and Avibactam (AVB) peaks was at 4.42 and 6.05 minutes, respectively. The developed method was validated according to ICH Q2 (R1) guidelines. The instrument precision for CEF& AVB had a %RSD of 0.24% and 0.12%, respectively. The Intra & Inter day precision for CEF & AVB had a %RSD of 0.39% and 0.19%, respectively.Method was linear and accurate for concentration range of 160-240g/ml and 40-60g/ml for CEF & AVB respectively, with regression coefficient of 0.999 for both CEF & AVB and % RSD for accuracy for CEF at 80%, 100% and 120% was found to be 0.89%, 0.11% and 0.36%, respectively; and for AVB at 80%, 100% and 120% was found to be 0.14%, 0.09% and 0.15% respectively. The LOD & LOQ for CEF are 3.69g/ml and 11.19g/ml respectively and the LOD & LOQ for AVB are 1.52g/ml and 4.60 g/ml respectively.

Article Details