Validation of two spectrophotometric methods for fluoxetine quantification

Abstract

Objective: This paper describes the development and validation of two UV-Visible spectrophotometric analysis methods, using absolute ethanol (method A) and HCl 0.1 M (method B) as solvents, to quantify fluoxetine (FLX) in its generic and brand name form. The objective is to validate both methods and compare the concentrations of the samples obtained from each one. Methods: Validation of each method with the determination of linearity, limit of detection and quantification, intermediary precision, robustness, accuracy and uniformity of mass for both samples was performed. Results: Uniform distribution of FLX in capsules were verified and good linear relationships were found between the readings and the concentrations of FLX, in the ranges of 100 μg/ml to 300 μg/ml and 5 μg/ml to 25 μg/ml, for method A and B, respectively. The limit of quantification obtained was 9.96 μg/ml for method A and 0.87 μg/ml for method B. The limit of detection obtained was 2.988 μg/ml for method A and 0.26 μg/ml for method B. Was also verified robustness, good inter-day precision and accuracy of both methods. Conclusion: The methods were successfully validated to the determination of FLX in its pharmaceutical formulations.