Pharmaceutical Sciences & Analytical Research Journal ISSN: 2640-6659
Research Article
Development and Validation of UV Spectrophotometric Method for the Determination of Latest Anti-Fungal Drug Oteseconazole in Pharmaceutical Dosage Form
Published: 2024-11-07

Abstract

A simple, precise, and accurate UV spectrophotometric method was developed and validated for the estimation of Oteseconazole in tablet dosage form. The analysis was performed at a wavelength of 223.3 nm, and the method followed Beer-Lambert’s law in the concentration range of 2.50 -15.00 μg/mL with a regression equation of y = 0.14434x + 0.00186, and a high correlation coefficient (R² = 0.99986). The slope was found to be 0.14434, indicating good sensitivity. The method demonstrated excellent accuracy, with a percentage recovery ranging from 99.9 % to 101.1 %. Precision studies showed low % RSD values for both intraday (0.61%) and interday (0.48 %) precision, confirming the method’s reliability. Robustness was assessed by varying the detection wavelength (± 5 nm), and the method showed recovery values of 100.0 % to 100.2 %. The forced degradation study of the UV method for OTEZ involved subjecting the sample to various stress conditions, including acid, alkali, peroxide, reduction, thermal, photolytic, and hydrolytic treatments.

Keywords

Oteseconazole; Validation; Ultraviolet Spectroscopy; Method Development