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

Mohammed Ali Salih; Dlivan Fattah Aziz; Salar Ibrahim Ali

doi:10.24017/science.2020.ICHMS2020.7

Authors

Mohammed Ali Salih Chemistry Department, College of Science,University of Sulaimani, Sulaimani, Iraq
Dlivan Fattah Aziz College of Pharmacy, University of Sulaimani, Sulaimani, Iraq
Salar Ibrahim Ali Nursing Department, Technical College of Health , Sulaimani Polytechnic University , Sulaimani, Iraq

Abstract

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.

Keywords:

RP-HPLC, Ketotifen Fumarate, Syrup, Validation and Chromatography.

References

[1] V. Kovalenko, A. Viktorova, "Compendium 2012-drugs," Morion, Kiev, pp. 1-1408, 2014.
[2] S. Thomas, "Antihistamine poisoning," Medicine, 40(3), pp. 109-110, 2012.
https://doi.org/10.1016/j.mpmed.2011.12.012
[3] M. Khater, Y. Issa, S. Mohammed, "Flow injection determination of ketotifen fumarate using PVC membrane selective electrodes," Bioelectrochemistry, 77(1), pp. 53-59, 2009.
https://doi.org/10.1016/j.bioelechem.2009.06.017
[4] N. Fei, L. Jiuru, "Determination of ketotifen by using calcein as chemiluminescence reagent," Analytica chimica acta, 592(2), pp. 168-172, 2007.
https://doi.org/10.1016/j.aca.2007.04.041
[5] Mokhtari, M. Ghazaeian, M. Maghsoudi, M. Keyvanfard, I., "EmamiSimple chemiluminescence determination of ketotifen using tris (1, 10 phenanthroline) ruthenium (II)-Ce (IV) system," Luminescence, 30(7), pp. 1094-1100. 2015.
https://doi.org/10.1002/bio.2864
[6] S. Tzvetanov, M. Vatsova, A. Drenska, J. Gorantcheva, N. Tyutyulkova, "Gas chromatographic-mass spectrometric method for quantitative determination of ketotifen in human plasma after enzyme hydrolysis of conjugated ketotifen," Journal of Chromatography B: Biomedical Sciences and Applications, 732(1), pp. 251-256, 1999.
https://doi.org/10.1016/S0378-4347(99)00289-3
[7] C. Julien-Larose, M. Guerret, D. Lavene, J. Kiechel, "Quantification of ketotifen and its metabolites in human plasma by gas chromatography mass spectrometry," Biomedical mass spectrometry, 10(3), pp. 136-142, 1983.
https://doi.org/10.1002/bms.1200100307
[8] H. Leis, E. Malle, "Deuterium-labeling and quantitative measurement of Ketotifen in human plasma by gas chromatography/negative ion chemical ionization mass spectrometry," Biological mass spectrometry, 20(8), pp. 467-470, 1991.
https://doi.org/10.1002/bms.1200200806
[9] H. Maurer, K. Pfleger, "Identification and differentiation of alkylamine antihistamines and their metabolites in urine by computerized gas chromatography-mass spectrometry," Journal of Chromatography B: Biomedical Sciences and Applications, 430, pp. 31-41, 1988.
https://doi.org/10.1016/S0378-4347(00)83131-X
[10] Grahnén A, Lönnebo A, Beck O, Eckernäs SÅ, Dahlström B, Lindström B. Pharmacokinetics of ketotiffn after oral administration to healthy male subjects. Biopharmaceutics & drug disposition. 1992 May;13(4):255-62.
https://doi.org/10.1002/bdd.2510130404
[11] E. Sieradzki, M. Grundkowska, H. Letmanska, "Ketotifen determination in serum by gas chromatography," Farm Pol, 45, pp. 160-162, 1989.