Abstract

Green, economic and sensitive two spectrofluorometric methods were developed for the quantitation of flibanserin (FB) in different matrices, which are based on FB native fluorescence properties. The first technique depends on measuring the relative fluorescence intensity of FB directly at emission and excitation wavelengths(λem/λex) (371 nm/247 nm), while the second technique is a first derivative (D1) spectrofluorometric method, which depends on measuring the peak amplitudes at 351 nm. Linear regressions were observed in the range of 0.1–1.5 μg/mL for both methods. Moreover, both methods were efficiently extended to analyze FB in human urine, indicating the ultra-sensitivity of the methods, and linear regression was found within a range 0.05–0.7 μg/mL for both methods. Excellent selectivity of the proposed methods and good recoveries were obtained upon the analysis of FB in pharmaceutical dosage form and human urine samples without interference from matrix components with acceptable ranges, from 98.86 to 101.46% and from 98.08 to 102.37%, respectively. Greenness of the developed methods was assessed using the national environmental method index (NEMI) and Analytical Eco-scale and Green Analytical Procedure Index (GAPI). The three approaches confirmed that the developed methods are green, safe and environment-friendly.

Highlights

  • Flibanserin (FB) (Figure 1) is a benzimidazole derivative that is chemically known as1-(2-4-(3-trifluoromethyl-phenyl) piperazin-1-yl)ethyl)benzimidazol-(1H)-2-one [1]

  • This behavior causes a reduction in the serotonin level in the brain, as well as the elevation of norepinephrine neurotransmitters, which results in the improvement of sexual functioning in premenopausal women [4,5,6]

  • It was approved by the FDA in 2015 for the management of patients with hyposexual desire disorder (HSDD) [7]

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Summary

Introduction

Flibanserin (FB) (Figure 1) is a benzimidazole derivative that is chemically known as. FB improves the sexual desire for premenopausal women suffering from hyposexual disorder by its multifunctional behavior as a serotonin agonist at the 5-HT1A receptors and/or antagonist at the 5-HT2A receptors [2,3] This behavior causes a reduction in the serotonin level in the brain, as well as the elevation of norepinephrine neurotransmitters, which results in the improvement of sexual functioning in premenopausal women [4,5,6]. It was approved by the FDA in 2015 for the management of patients with hyposexual desire disorder (HSDD) [7].

Chemical
Discussion
Method Validation of Spectrofluorometric Methods in Ethanolic Solution
Linearity
LOD and LOQ
Accuracy and Precision
Method Validation of Spectrofluorometric Methods in Human Urine
Analysis of the Pharmaceutical Dosage Form
Method
Analysis in Real Human Urine Samples
Greenness Evaluation of the Proposed Spectrofluorometric Methods
Methods
Reagents and Materials
Preparation of a Standard Solution of FB
Calibration Curves
Analysis of FB in Pharmaceutical Dosage Form
Assay of FB in Human Urine and the Application to Real Samples
Conclusions
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