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Analytical Methods Development and Validation for Simultaneous Estimation of Prednisolone and Itraconazole in Synthetic Mixture

Year: 2026

Type: article

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.

Source: World Journal of Pharmaceutical Research

Author: Shruti Panchal1, Dr. Divyakant Patel2, Dr. Bhumi R. Patel3*, Mr. Jaymin G. Patel3, Mr. Ronak N. Patel3

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W7157603935

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