Abstract

A REVIEW OF METHOD DEVELOPMENT AND VALIDATION OF SOLID DOSAGE FORM OF QUETIAPINE FUMARATE BY UV SPECTROSCOPY

Vignesh Elumalai*, Dravid Jayam, Manikandan Sivakumar, Seenuvasan Elumalai

Abstract

A review of the method development and validation of quetiapine fumarate by UV spectroscopy using 0.1M HCl solution is presented. The method involves the measurement of absorbance at 242 nm, and its validation was performed according to International Conference on Harmonization (ICH) guidelines. The method was found to be specific, linear, accurate, precise, and robust. The linearity range was 5-25 μg/mL, with a correlation coefficient (R2) of 0.999. limit of quantitation (LOQ) were 3 μg/mL, respectively. The method was applied to the analysis of quetiapine fumarate in pharmaceutical formulations, and the results were found to be satisfactory. This review highlights the suitability of UV spectroscopy using 0.1M HCl solution for the analysis of quetiapine fumarate in pharmaceutical solid dosage form.

Keywords: Quetiapine fumarate, UV spectroscopy, 0.1M HCl solution, method development, method validation, pharmaceutical analysis.