Analytical Method of Development and Validation of Hydrocortisone by UV Spectroscopic Method
Abstract
The present investigation aimed at establishing and validating a UV spectrophotometric method for the quantitative determination of hydrocortisone (HC) in its pure form and pharmaceutical dosage formulations, employing multivariate linear regression analysis. Analytical approach exploited the quantitative relationship between drug concentration and measured absorbance values at five selected wavelengths (238, 240, 242, 244, and 246 nm). The method was validated according to the International Conference on Harmonization (ICH) Q2(R1) guidelines for linearity, range, precision, accuracy, and assay. Linearity was demonstrated over a concentration range of 6–14 µg/mL with a correlation coefficient exceeding 0.999. The accuracy, assessed by recovery studies, was found within 98.2–102%, and the precision (% RSD) was below 2% for both interday and intraday studies, with the exception of the HISONE 5 mg formulation. This method provides a viable alternative for routine quality control of hydrocortisone in pharmaceutical formulations.
How to Cite This Article
Shantanu Rohidas Mane, Monika Balaji Ingale, Viki Kinkar Dilip (2026). Analytical Method of Development and Validation of Hydrocortisone by UV Spectroscopic Method . International Journal of Pharma Growth Research Review (IJPGARR), 3(4), 01-05. DOI: https://doi.org/10.54660/IJPGRR.2026.3.4.01-05