Abstract

Objective: The objectives of the present study were to develop and validate a mass compatible ultra-performance liquid chromatography (UPLC) method to quantify the impurities in fluticasone nasal spray, and to establish a suitable container-closure system for the formulation.
 Methods: A gradient method was optimized with a flow rate of 0.5 ml/min, detector wavelength-240 nm, run time-25 min and 0.1% Trifluoroacetic acid (TFA) in water as solvent A and Methanol as solvent B.
 Results: The developed method was linear over the range of 0.07-1.10 µg/ml for impurity-I, 0.16-2.47 µg/ml for impurity-II, 0.67-10.0 µg/ml for impurity-III, and 1.29-19.3 µg/ml for impurity-IV. The limit of quantification (LOQ) and limit of detection (LOD) were established as 0.07 and 0.02 µg/ml, 0.14 and 0.05 µg/ml, 0.59 and 0.19 µg/ml, 1.06 and 0.35 µg/ml for impurities I-IV respectively. The percent relative standard deviation (%RSD) of the replicate analysis for impurities I-IV, was within the acceptance criteria (0.4, 0.2, 0.3, and 0.1% respectively) that proved the precision of the method. The accuracy of the method was studied from 50%-150% of test concentration and the results ranged from 100.3% to 109.4%. The container-closure compatibility study revealed that the solution stored in the glass container system did not generate any additional peaks in the chromatogram.
 Conclusion: Hence, the developed method can be employed by quality testing laboratories to quantify impurities in fluticasone propionate nasal spray. The study also suggests that glass containers could serve as a compatible system for the storage of fluticasone propionate nasal solution.

Highlights

  • Asthma and allergic rhinitis are common respiratory conditions associated with airway inflammation

  • The container-closure compatibility study revealed that the chromatogram of the fluticasone propionate nasal solution stored in a glass container was in concurrence with the chromatogram of freshly prepared solution

  • We have developed and validated a novel, sensitive, reproducible, and accurate mass compatible ultra-performance liquid chromatography (UPLC) method, for the quantification of impurities in the fluticasone propionate nasal spray

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Summary

Introduction

Asthma and allergic rhinitis are common respiratory conditions associated with airway inflammation. Common symptoms of allergic rhinitis are nasal congestion, rhinorrhea, sneezing, nasal itch, and postnasal drainage [1]. Over time, almost entirely replaced treatments based on oral corticosteroids, which commonly produced major adverse effects. These drugs, because of topical application, present a substantially better therapeutic index than oral steroids [3]. The treatment of allergic rhinitis has been revolutionized by the introduction of topical nasal steroid sprays, which are the most common medications prescribed by otolaryngology professionals, given that the regular use of these sprays reduces nasal obstruction, rhinorrhea, and overall nasal symptom scores [4, 5]

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