DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF VILANTEROL AND FLUTICASONE FUROATE IN PHARMACEUTICAL FORMULATIONS
DOI:
https://doi.org/10.22159/ajpcr.2017.v10i4.16748Abstract
Objective: To develop a simple, rapid, precise, accurate, sensitive spectrophotometric methods (A&B) were developed for simultaneous estimation and validation of Vilanterol (VTL) and Fluticasone Furoate (FFE) in pure and tablet dosage forms.
Method:  Method A is a simultaneous equation method and method B is a first order derivative spectrophotometric method. Pure drug samples of VTL and FFE were dissolved in a mixture of Methanol and Ethanol in the ratio of 1:1 (v/v) and found to have absorbance maxima at 231nm for VTL and 260nm for FFE respectively
Results: The linearity lies between 2.5–10µg/ml for VTL and 10–60µg/ml for FFE in these two methods (A&B). The correlation coefficient (r2) was found to be 0.999 for both VTL and FFE, the limit of detection and limit of quantification were found to be 0.015µg/ml and 0.05µg/ml for VTL and 0.05µg/ml and 0.2µg/ml for FFE respectively. The results of analysis have been validated statistically by recovery studies as per ICH guidelines.
Conclusion: The two methods A&B showed good reproducibility and recovery with % RSD less than 2. Hence both methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of VTL and FFE in pure and combined dosage form.
Keywords: Fluticasone furoate, Vilanterol, Derivative spectrophotometric, Simultaneous equation method, Method development and validation.
Downloads
References
References:
Allen A, Schenkenberger I, Trivedi R, Cole J, Hicks W, Gul N, Jacques L. Inhaled fluticasone furoate/vilanterol does not affect hypothalamic-pituitary-adrenal axis function in adolescent and adult asthma: randomised, double-blind, placebo-controlled study. Clin Respir J 2013;7(4):397-406.
Bruni FM, De Luca G, Venturoli V, Boner AL. Intranasal corticosteroids and adrenal suppression .Neuroimmunomodulation 2009; 16 (5): 353–62.
Allen A, Bareille PJ, Rousell VM. Fluticasone furoate, a novel inhaled corticosteroid, demonstrates prolonged lung absorption kinetics in man compared with inhaled fluticasone propionate. Clin Pharmacokinet 2013; 52(1):37-42.
Tamm M, Richards DH, Beghe B, Fabbri L. Inhaled corticosteroid and long-acting beta2-agonist pharmacological profiles: effective asthma therapy in practice. Respir Med 2012; 106 Suppl 1:S9-19.
Harrell AW, Siederer SK, Bal J, Patel NH, Young GC, Felgate CC, et al. Metabolism and disposition of vilanterol, a long-acting beta(2)-adrenoceptor agonist for inhalation use in humans. Drug Metab Dispos 2013; 41(1):89-100.
Spyratos D, Sichletidis L. Umeclidinium bromide/vilanterol combination in the treatment of chronic obstructive pulmonary disease: a review. Ther Clin Risk Manag 2015; 11:481-487.
Trivedi RK, Challa S, Patel MC. Trivedi DR. And Chatrabhuji PM. A Rapid, Stability-Indicating RP-UPLC Method for the Simultaneous Determination of Fluticasone Furoate and Benzalkonium Chloride in a Pulmonary Drug Product. Chem Sci Trans 2013; 2(4), 1184-1191.
ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1), International Conference on Harmonisation, 2005.
ICH Stability Testing: Photo Stability Testing of New Drug Substances and Products Q1B, International Conference on Harmonisation, 2005.
ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonisation, 2005.
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.
