Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ITRACONAZOLE IN SOLID

Ankit Singh, Sharma Hemanshi, Shah Dipti, Aaishkhan Pathan and Manisha Kotadiya*

ABSTRACT

Aim and Objectives: The aim of present study is to develop a simple, accurate, and cost-effective UV spectrophotometric method and validate for the quantitative determination of Itraconazole in capsule dosage form. Methods: The method is based on the measurement of absorbance at a maximum wavelength of 255 nm in methanol as the solvent. The method was validated in accordance with ICH guidelines for accuracy, precision, linearity, and reproducibility. Results: Itraconazole exhibited good linearity in the concentration range of 16–24 µg/mL, with a correlation coefficient (R²) greater than 0.999, indicating excellent linearity. Recovery studies showed results within the acceptable range of 97–103%, confirming the accuracy of the method. Conclusion: The developed UV spectrophotometric method has been successfully applied for routine quality control analysis of Itraconazole in capsule solid dosage form.

Keywords: UV, Validation, Accuracy, Regression, Antifungal.