Abstract

ANALYTICAL METHODS DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PREDNISOLONE AND ITRACONAZOLE IN SYNTHETIC MIXTURE

Shruti Panchal, Dr. Divyakant Patel, Dr. Bhumi R. Patel*, Mr. Jaymin G. Patel, Mr. Ronak N. Patel

Abstract

The objective of this study was to develop and validate a precise, accurate, and reliable RP-HPLC method for the simultaneous estimation of Prednisolone and Itraconazole in a synthetic mixture according to ICH guidelines. Identification tests such as melting point, solubility, FT-IR, and UV analysis were performed for both drugs. In the RP-HPLC method, a mobile phase consisting of acetonitrile, phosphate buffer, and methanol was used, providing well-resolved peaks with suitable retention times. The method was developed and optimized for effective separation and analysis. The method showed excellent linearity, precision, and accuracy, with a correlation coefficient close to 1. Recovery studies were within acceptable limits, and low LOD and LOQ values indicated high sensitivity. The percentage assay value was close to 100%, confirming the reliability of the method. No interference from excipients was observed. The developed RP-HPLC method was found to be accurate, precise, economical, and reproducible. This method is suitable for routine quality control analysis of Prednisolone and Itraconazole in synthetic mixtures.

Keywords: Prednisolone, Itraconazole, Synthetic Mixture, and RP-HPLC Methods Development and Validation.