Development of a stability-indicating HPLC method for the simultaneous quantification of antazoline nitrate and naphazoline sulfate in a commercial ophthalmic formulation

References

• Goodman, L. S. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. Vol. 1549; McGraw-Hill: New York, 1996.
   Google Scholar
• Casado-Terrones, S.; Fernández-Sánchez, J. F.; Díaz, B. C.; Carretero, A. S.; Fernández-Gutiérrez, A. A Fluorescence Optosensor for Analyzing Naphazoline in Pharmaceutical Preparations: Comparison with Other Sensors. J. Pharm. Biomed. Anal. 2005, 38, 785–789. DOI: 10.1016/j.jpba.2005.02.018.
   PubMed Web of Science ®Google Scholar
• Cole, P.; Haight, S.; Cooper, W.; Kassel, E. A Computed Tomographic Study of Nasal Mucosa: effects of Vasoactive Substances. J. Otolaryngol. 1983, 12, 58–60.
   PubMedGoogle Scholar
• Hajian, R.; Shams, N.; Kaedi, I. Application of Ratio Derivative Spectrophotometry for Simultaneous Determination of Naphazoline and Antazoline in Eye Drops. E-J. Chem. 2010, 7, 1530–1538. DOI: 10.1155/2010/493027.
   Google Scholar
• Berdeu, D.; Puech, R.; Ribes, G.; Loubatières-Mariani, M. M.; Bertrand, G. Antazoline Increases Insulin Secretion and Improves Glucose Tolerance in Rats and Dogs. Eur. J. Pharmacol. 1997, 324, 233–239. DOI: 10.1016/s0014-2999(97)00126-x.
   PubMed Web of Science ®Google Scholar
• Najib, F. M.; Aziz, K. H. Spectrophotometric Determination of Lamotrigine in Pharmaceutical Preparations and Urine Samples Using Bromothymol Blue and Bromophenol Blue. Malaysian J. Anal. Sci. 2013, 17, 310–325.
   Google Scholar
• Gutiérrez, A. F.; Carretero, A. S.; Díaz, B. C.; Blanco, C. C. Determination of the Drug Naphazoline in Pharmaceutical Preparations by Heavy Atom-Induced Room-Temperature Phosphorescence. Appl. Spectrosc. 1999, 53, 741–744. DOI: 10.1366/0003702991947199.
   Web of Science ®Google Scholar
• Khalil, S. Analytical Application of Atomic Emission and Atomic Absorption Spectrometry for the Determination of Imidazoline Derivatives Based on Formation of Ion-Associates with Sodium Cobaltinitrite and Potassium Ferricyanide. Mikrochim. Acta. 1999, 130, 181–184. DOI: 10.1007/BF01244925.
   Google Scholar
• Yesilada, A.; Tozkoparan, B.; Gökhan, N.; Öner, L.; Ertan, M. Development and Validation of a Capillary Electrophoretic Method for the Determination of Degradation Product in Naphazoline HCl Bulk Drug Substance. J. Liq. Chromatogr. Relat. Technol. 1998, 21, 2575–2588. DOI: 10.1080/10826079808003408.
   Web of Science ®Google Scholar
• Joseph-Charles, J.; Bertucat, M. Simultaneous determination of naphazoline nitrate and tetramethylthionine base in eye drops by first-derivative UV spectrophotometry. 1999.
   Google Scholar
• European Medicines Agency Guideline, I. H. T. Validation of analytical procedures Q2 (R1). Geneva, CH: International Conference of Harmonization for Better Health, 2022.
   Google Scholar
• Boon, P.; Sudds, W. The Gas Chromatographic Determination of Imidazolines in Pharmaceutical Preparations. J. Pharm. Pharmacol. 1967, 19, p88S–92S.
   Web of Science ®Google Scholar
• Chocholouš, P.; Šatínský, D.; Solich, P. Fast Simultaneous Spectrophotometric Determination of Naphazoline Nitrate and Methylparaben by Sequential Injection Chromatography. Talanta. 2006, 70, 408–413. DOI: 10.1016/j.talanta.2006.02.065.
   PubMed Web of Science ®Google Scholar
• Kelani, K. M.; Hegazy, M. A.; Hassan, A. M.; Tantawy, M. A. A Green TLC Densitometric Method for the Simultaneous Detection and Quantification of Naphazoline HCl, Pheniramine Maleate along with Three Official Impurities. BMC Chem. 2022, 16, 1–11. DOI: 10.1186/s13065-022-00819-9.
   PubMed Web of Science ®Google Scholar
• Sa ‘sa’, S.; Al-Momani, I.; Jalal, I. Determination of Naphazoline Nitrate and Antazoline Sulphate in Pharmaceutical Combinations by Reversed-Phase HPLC. Anal. Lett. 1990, 23, 953–971. DOI: 10.1080/00032719008053438.
   Web of Science ®Google Scholar
• Ruckmick, S. C.; Marsh, D. F.; Duong, S. T. Synthesis and Identification of the Primary Degradation Product in a Commercial Ophthalmic Formulation Using NMR, Ms, and a Stability-Indicating HPLC Method for Antazoline and Naphazoline. J. Pharm. Sci. 1995, 84, 502–507. DOI: 10.1002/jps.2600840422.
   PubMed Web of Science ®Google Scholar
• Korodi, T.; Dulavová, M.; Urban, E.; Kopelent-Frank, H.; Lachmann, B. A Stability-Indicating HPLC Method for the Determination of Naphazoline and Its Degradation Product and Methyl Parahydroxybenzoate in Pharmaceutical Preparations. J. Liq. Chromatogr. Relat. Technol. 2014, 37, 1321–1333. DOI: 10.1080/10826076.2013.789802.
   Web of Science ®Google Scholar
• Ribeiro, M. M. A. C.; Oliveira, T. C.; Batista, A. D.; Muñoz, R. A. A.; Richter, E. M. A Sub-Minute Electrophoretic Method for Simultaneous Determination of Naphazoline and Zinc. J. Chromatogr. A. 2016, 1472, 134–137. DOI: 10.1016/j.chroma.2016.10.031.
   PubMed Web of Science ®Google Scholar