Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation Patil Shivprasad*, Dr. Kshirsagar Ajay, Ade Kartik, Bharkade Akash, Bharkade Madhav, Birkalwar Ashish, Chandolkar Mahesh Department of Pharmaceutical Quality Assurance, D. K. Patil Institute of Pharmacy, Loha, Maharashtra, India *Corresponding Author E-mail: shivprasad2829@gmail.com
Online Published on 03 October, 2023. Abstract The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms. Top Keywords UV spectroscopy, Method development, Validation, Formulation, Posaconazole. Top |