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Research Journal of Pharmacy and Technology
Year : 2017, Volume : 10, Issue : 11
First page : ( 3928) Last page : ( 3932)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2017.00713.2

Development and validation of UV spectrophotometric methods for the estimation of vortioxetine hydrobromide in bulk and pharmaceutical dosage forms

Pravallika K.E., Ravi P., Abboodi Abdullah Hasan, Razzaq Ahmed Hayder, Sasivardhan O.

Dept of Pharmacy, Acharya Nagarjuna University College of Pharmaceutical Sciences, Acharya Nagarjuna University, Guntur

Online published on 26 March, 2018.

Abstract

The research work discusses the development of simple, selective, precise and rapid spectrophotometric methods for determination of vortioxetine hydrobromide in bulk and pharmaceutical dosage form. Two methods were developed using different solvents, methanol (method A) and 50: 50% v/v of water: methanol (method B). The vortioxetine hydrobromide quantified at 228nm in method A and 224nm in method B. Both the methods are high sensitive and obeyed beers-lamberts law over the concentration ranges of 2–12 and 3–15 μg/ml−1 for method A and method B respectively and exhibited good correlation coefficient (R2 =0.999). The linear regression equation obtained by least square regression method was Y=0.061x+0.01 and Y=0.061X+0.03 for method A and method B respectively. Two methods were shown the excellent mean recovery of 98.3–100.7 and 98.5–100.3 for method A and method B respectively. Both optimized methods showed the good reproducibility and recovery with standard deviation <1% and percent relative standard deviation <2%. The proposed method A and B was validated for various parameters like accuracy, precision, robustness, ruggedness, limit of detection and limit of quantification as per ICH guidelines and statically. The obtained results proved that proposed methods are precise and accurate and hence can be applied for routine analysis of the vortioxetine hydrobromide in bulk and pharmaceutical dosage forms in quality control purpose.

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Keywords

Vortioxetine hydrobromide, methanol, water, beers-lamberts law, validation.

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