Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method

Pulusu, V.; Kommarajula, P.

Growing Science » Current Chemistry Letters » Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method

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Current Chemistry Letters

ISSN 1927-730x (Online) - ISSN 1927-7296 (Print) Quarterly Publication Volume 11 Issue 2 pp. 237-244 , 2022

Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method Pages 237-244 Download PDF

Authors: Veera Shakar Pulusu, Parasharamulu Kommarajula

DOI: 10.5267/j.ccl.2021.11.004

Keywords: Flibanserin, RP-HPLC, Development, Validation, ICH Guidelines

Abstract: Flibanserin (Addyi) is a medication used to treat women who have not gone through menopause who have low sexual desire. Specific and simple stability indicating method was developed and validated by high-performance liquid chromatography (RP-HPLC) for the determination of Flibanserin. Separation was carried out by using a mobile phase consisting of 0.01M Potassium phosphate monohydrate buffer (KH₂PO₄) pH 3.50 buffer: Acetonitrile in the ratio of 60:40. The column used was Agilent C18, (150×4.6) mm, 5µm with a flow rate of 1.0ml/min and temperature at 30°C. The detection was carried out at 248 nm and Flibanserin was eluted at around 2.8min. This method was validated as per ICH guidelines and validation included specificity, precision, linearity, accuracy, forced degradation, and robustness. Forced degradation was conducted under the conditions of hydrolysis, oxidation, thermal, acid, base, and peroxide hydrolysis. The calibration curve was linear over the concentration range from 20 to 200µg/mL and the coefficient of determination (r²) was observed as 0.9998. The precision and accuracy of the method were within the acceptable range. The results of this study showed that the validated method is simple and accurate, which confirmed that the method is suitable for the determination of Flibanserin.

How to cite this paper

 Pulusu, V & Kommarajula, P. (2022). Analytical method development and validation for the determination of Flibanserin using reverse phase HPLC method.Current Chemistry Letters, 11(2), 237-244.

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