Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography

The goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performa...

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Main Authors: Mohammed Ali Salih, Dlivan Fattah Aziz, Salar Ibrahim Ali
Format: Article
Language:English
Published: Sulaimani Polytechnic University 2020-12-01
Series:Kurdistan Journal of Applied Research
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Online Access:https://kjar.spu.edu.iq/index.php/kjar/article/view/577
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author Mohammed Ali Salih
Dlivan Fattah Aziz
Salar Ibrahim Ali
author_facet Mohammed Ali Salih
Dlivan Fattah Aziz
Salar Ibrahim Ali
author_sort Mohammed Ali Salih
collection DOAJ
description The goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performance liquid chromatography was advanced for the simultaneous assessment of ketotifen fumarate in the liquid syrup dosage type. The HPLC system using isocratic elution method with reverse-phase Inertsil ODS-(250 mm × 4.6 mm, 3 ?m) column was detected by ultraviolet absorbance at 297 nm with no interference from widely using excipients, the mobile phase (A) is a mixture of triethylamine and water (175 ?l in 500 ml of water), and the mobile phase (B) is a mixture of triethylamine and methanol (175 ?l in 500 ml of methanol) at a flow rate of 1.5 mL/min (mobile phase A 40 %:mobile phase B 60%) at column temperature using 40 ° C, the retention time for ketotifen fumarate was 6.4±0.5 min. The concentration curves were linear in the range of 10.0 to 35.0 ?g / ml (R2 = 0.9999). The developed method was tested for the specificity, precision, linearity, precision, reliability, robustness, and consistency of the solution. The regeneration of ketotifen fumarate in formulations was found to be 99.75 %, 99.91 %, and 100.05 % respectively. The percent RSD for percent recovery was found to be 0.21 and 0.17 and 0.10 for ketotifen fumarate. In the conclusion, the suggested technique was successfully used for the quantitative determination of ketotifen fumarate in formulations.
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spelling doaj-art-6ca65ac5c9eb48659e21f5fe6eb896d12025-02-09T21:00:00ZengSulaimani Polytechnic UniversityKurdistan Journal of Applied Research2411-76842411-77062020-12-016310.24017/science.2020.ICHMS2020.7Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid ChromatographyMohammed Ali Salih0Dlivan Fattah Aziz1Salar Ibrahim Ali2Chemistry Department, College of Science,University of Sulaimani, Sulaimani, IraqCollege of Pharmacy, University of Sulaimani, Sulaimani, IraqNursing Department, Technical College of Health , Sulaimani Polytechnic University , Sulaimani, IraqThe goal of the current study was to establish and authenticate an isocratic reverse-stage High-Performance Liquid Chromatography (HPLC) method for quantifying ketotifen fumarate (KF) in pharmaceutical liquid dosage compositions. Easy, quick, accurate, exact, and accurate reverse-stage high-performance liquid chromatography was advanced for the simultaneous assessment of ketotifen fumarate in the liquid syrup dosage type. The HPLC system using isocratic elution method with reverse-phase Inertsil ODS-(250 mm × 4.6 mm, 3 ?m) column was detected by ultraviolet absorbance at 297 nm with no interference from widely using excipients, the mobile phase (A) is a mixture of triethylamine and water (175 ?l in 500 ml of water), and the mobile phase (B) is a mixture of triethylamine and methanol (175 ?l in 500 ml of methanol) at a flow rate of 1.5 mL/min (mobile phase A 40 %:mobile phase B 60%) at column temperature using 40 ° C, the retention time for ketotifen fumarate was 6.4±0.5 min. The concentration curves were linear in the range of 10.0 to 35.0 ?g / ml (R2 = 0.9999). The developed method was tested for the specificity, precision, linearity, precision, reliability, robustness, and consistency of the solution. The regeneration of ketotifen fumarate in formulations was found to be 99.75 %, 99.91 %, and 100.05 % respectively. The percent RSD for percent recovery was found to be 0.21 and 0.17 and 0.10 for ketotifen fumarate. In the conclusion, the suggested technique was successfully used for the quantitative determination of ketotifen fumarate in formulations. https://kjar.spu.edu.iq/index.php/kjar/article/view/577RP-HPLC, Ketotifen Fumarate, Syrup, Validation and Chromatography.
spellingShingle Mohammed Ali Salih
Dlivan Fattah Aziz
Salar Ibrahim Ali
Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
Kurdistan Journal of Applied Research
RP-HPLC, Ketotifen Fumarate, Syrup, Validation and Chromatography.
title Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
title_full Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
title_fullStr Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
title_full_unstemmed Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
title_short Determination of Ketotifen Fumarate in Syrup Dosage Form by High Performance Liquid Chromatography
title_sort determination of ketotifen fumarate in syrup dosage form by high performance liquid chromatography
topic RP-HPLC, Ketotifen Fumarate, Syrup, Validation and Chromatography.
url https://kjar.spu.edu.iq/index.php/kjar/article/view/577
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AT dlivanfattahaziz determinationofketotifenfumarateinsyrupdosageformbyhighperformanceliquidchromatography
AT salaribrahimali determinationofketotifenfumarateinsyrupdosageformbyhighperformanceliquidchromatography