High-Performance Liquid Chromatography Using Monolithic Column for Simultaneous Determination of Oxymetazoline Hydrochloride and Xylometazoline Hydrochloride in Nasal Spray Formulations

Main Article Content

Somsak Sirichai
Manassawee Janrod

Abstract

In this research, a simple and rapid high-performance liquid chromatography for simultaneous determination of oxymetazoline hydrochloride and xylometazoline hydrochloride in nasal spray formulations was developed. The separation was conducted in monolithic column (C18, 100 mm x 4.6 mm). A mixture of acetonitrile (28% by volume) and 0.01% phosphoric acid (72% by volume) was used as the optimal mobile phase, with the flow rate of 2.50 mL/min. All analytes were detected at 220 nm. Under the optimized conditions, oxymetazoline hydrochloride and xylometazoline hydrochloride could be completely separated within 2 min. Calibration curves for standard solution of oxymetazoline hydrochloride and xylometazoline hydrochloride were in the range of 0.50-10.00 mg/L with R2 > 0.9987. Limits of detection of oxymetazoline hydrochloride and xylometazoline hydrochloride were 0.03 and 0.04 mg/L, respectively. The proposed method can be used for routine analysis of oxymetazoline hydrochloride and xylometazoline hydrochloride in nasal spray formulations.

Article Details

Section
Research Ariticles

References

Moffat AC, Osselton MD, Widdop B, editors. Clarke’s Analysis of Drugs and Poisons. 4th ed. London: Pharmaceutical Press; 2011.

Abdel-Aziz O, El-Kosasy AM, Magdy N, El Zahar NM. Novel spectroscopic methods for determination of Cromolyn sodium and Oxymetazoline hydrochloride in binary mixture. Spectrochim Acta A Mol Biomol Spectrosc [Internet]. 2014;131:59-66. Available from: https://doi.org/10.1016/j.saa.2014.04.047

Saleh S, Lotfy H, Hassan N, Elgizawy S. Spectrophotometric and chromatographic methods for the determination of a binary mixture of sodium cromoglicate and xylometazoline hydrochloride. Anal Chem Indian J. 2013;13:152-60.

Othman N, Fathe S. Indirect Spectrophotometric Determination of Oxymetazoline Hydrochloride. Rafidain J Sci [Internet]. 2013;24:84-95. Available from: https://doi.org/10.33899/rjs.2013.67503.

Humeidy I. Spectrophotometric method for Determination of oxymetazoline, HCl in a Pharmaceutical formulation using 2,4-dinitrophenylhydrazine. Tikrit J Pure Sci [Internet]. 2015;20(2). Available from: https://doi.org/10.25130/tjps.v20i2.1165.

Wahdan K, Alnedawi Z, Hassan AM, Hadi H, Shabana A. Cloud Point Pre-concentration with Spectrophotometric Detection for Determination of Oxymetazoline in Pharmaceutical Formulations. Chem Sci J [Internet]. 2021;12(3):1-5.

Sioufi A, Leroux F, Dubois JP. Determination of xylometazoline in plasma and urine by gas chromatography using a fused-silica capillary column and an electron-capture detector. J Chromatogr [Internet]. 1989;487(1):81-9. Available from: https://doi.org/10.1016/s0378-4347(00)83009-1.

Alnedawi Z, Hassan AM, Hadi H, Shabana A. Development HPLC technique for determining Oxymetazoline and Isoxspurine in pharmaceutical formulations. Egypt J Chem [Internet]. 2022;65(11):779-84. Available from: https://doi.org/10.21608/ejchem.2022.151275.6551.

Raju MD. Method development and validation of Oxymetazoline HCl and Sorbitol in bulk and pharmaceutical dosage form. J Emerg Technol Innov Res [Internet]. 2019 Jun;6(6):243-50. Available from: https://www.jetir.org/papers/JETIR1906324.pdf.

Sreelakshmi M, Sasidhar RC, Raviteja B. Reverse phase-HPLC method for simultaneous estimation of tetracaine and oxymetazoline in bulk samples. J Pharm Sci Res. 2017;9(9):1589-94.

Mikawy NN, Magdy N, Mohamed MH, El-Kosasy AM. Validated HPLC method for simultaneous determination of azelastine hydrochloride fluticasone propionate and oxymetazoline in nasal mucosa and nasopharyngeal swabs from real human samples. Sci Rep [Internet]. 2025;15(1):4252. Available from: https://doi.org/10.1038/s41598-024-82387-7.

Kasawar GB, Farooqui M. Development and validation of a stability indicating RP-HPLC method for the simultaneous determination of related substances of albuterol sulfate and ipratropium bromide in nasal solution. J Pharm Biomed Anal [Internet]. 2010;52(1):19-29. Available from: https://doi.org/10.1016/j.jpba.2009.11.026.

Alghamdi H, Alsaeedi M, Hayes PE, Glennon JD. Rapid and sensitive simultaneous separation and electrochemical detection of tetracaine hydrochloride and oxymetazoline hydrochloride in pharmaceutical formulations via core-shell reversed-phase liquid chromatography. J Pharm Biomed Anal [Internet]. 2022;214:114717. Available from: https://doi.org/10.1016/j.jpba. 2022.114717

Fathy ME, Abo El Abass Mohamed S, Elmansi H, Belal F. Simultaneous Determination of Cromolyn Sodium Combined Dosage Forms Using Isocratic HPLC Method. J Chromatogr Sci [Internet]. 2017;55(1):14-22. Available from: https://doi.org/10.1093/chromsci/bmw142.