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.
Shruti Panchal1, Dr. Divyakant Patel2, Dr. Bhumi R. Patel3*, Mr. Jaymin G. Patel3, Mr. Ronak N. Patel3 (Fri,) studied this question.