Development of Two Simple Spectrophotometric Methods to Assay Phenylephrine-HCl as Pure Form And in Its Drug Forms

This work includes the development of two spectrophotometric methods which are sensitive, accurate, stable, and has good recovery for the determination of phenylephrine-HCl as free form and in the pharmaceutical preparations. In the method (A), phenylephrine is oxidized by potassium permanganate in a basic solution of sodium hydroxide and the bluish-green color of the resulting manganate (MnO 42- ) is measured at wavelength 610 nm, which is linearly proportional to the amount of phenylephrine-HCl. Method (B), is involved the oxidation of phenylephrine-HCl by using an excess amount of N-bromosuccinimide in an acidic medium of hydrochloric acid solution, the remaining (unreacted) amount of N-bromosuccinimide is used to bleach indigo carmine dye and the absorbance of the blue color of the remaining dye is measured at the wavelength of 610 nm. which is directly proportional to the concentration of phenylephrine-HCl. The molar absorptivity coefficients of methods (A) and (B) are estimated and equal to 1.5722×10 4 and 5.5191×10 4 L/mol.cm, respectively. Beer’s law of the both methods are linear in the concentration ranges 0.2–8.0 µg/mL (method A) and 0.2–3.5 µg/mL (method B). The relative standard deviation values of methods (A) and (B) are also found to be better than 0.0286 and 0.0114, respectively. The two proposed methods are applied to estimate phenylephrine-HCl in injection and drop.

Keywords:

Indigo carmine, KMnO4, NBS, Oxidation Phenylephrine-HCl, Spectrophotometry,

PDF

___

1. K. Kareem N, Z. Thani M, F.Al-Rawi K. New approach for determination of Phenylephrine HCl in Pure and Pharmaceutical Formulation using a various Microextraction Methods. Res J Pharm Technol [Internet]. 2022 Apr 23;15(4):1648–52. Available from: .
2. Goth A. Medical Pharmacology: Principles and Concepts. Surv Anesthesiol [Internet]. 1961;5(6):642. Available from: .
3. Cartwright AC. The British pharmacopoeia, 1864 to 2014: medicines, international standards and the state. Routledge; 2016.
4. Barabde G, Pataskar P, Gaikar T, Bagul V, Patil T. Development and Validation of Fast, Simple RP-HPLC Method for Simultaneous Estimation of Brompheniramine, Dextromethorphan HBr and Phenylphrine HCl in Pharmaceutical Dosage Form. JAC. 2022;15(8):109–19.
5. Sonone R, Tandel L, Jain V. Novel Rapid Isocratic RP-HPLC Method for Simultaneous Estimation of Phenylephrine Hydrochloride, Paracetamol, Caffeine, Diphenhydramine Hydrochloride. Curr Pharm Anal [Internet]. 2021 Jul;17(6):792–800. Available from: .
6. Kommana R, Basappa P. Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Codeine Phosphate and Chlorpheniramine Maleate from Their Combined Liquid Dosage Form. Chromatogr Res Int [Internet]. 2013 Mar 31;2013:1–7. Available from: .
7. El Yazbi FA, Hassan EM, Khamis EF, Ragab MAA, Hamdy MMA. Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Two Binary Mixtures Containing Ketorolac Tromethamine with Phenylephrine Hydrochloride and with Febuxostat. J Chromatogr Sci [Internet]. 2016 May;54(5):819–28. Available from: .
8. Ragab MAA, Abdel-Hay MH, Ahmed HM, Mohyeldin SM. Determination of Ibuprofen and Phenylephrine in Tablets by High-Performance Thin Layer Chromatography and in Plasma by High-Performance Liquid Chromatography with Diode Array Detection. J Chromatogr Sci [Internet]. 2019 Aug 1;57(7):592–9. Available from: .
9. Nagarjuna P, Tharun Kumar B, Nalluri BN. Simultaneous Analysis of Phenylephrine HCl and Ketorolac Tromethamine in Bulk and Injectable Formulations by RP-HPLC-PDA Method. J Drug Deliv Ther [Internet]. 2020 Aug 15;10(4-s):39–45. Available from: .
10. Yagmur S, Ture M, Saglikoglu G, Sadikoglu M, Yilmaz S. The Quantitative Detection of Phenylephrine in Pharmaceutical Preparations and Spiked Human Urine by Voltammetry. Russ J Electrochem [Internet]. 2018 Oct 15;54(10):741–6. Available from: .
11. Amare M, Menkir G. Differential pulse voltammetric determination of salbutamol sulfate in syrup pharmaceutical formulation using poly(4-amino-3-hydroxynaphthalene sulfonic acid) modified glassy carbon electrode. Heliyon [Internet]. 2017 Oct 1;3(10):e00417. Available from: .
12. H. Hasan S, S. Othman N, M. Surchi K. Determination of Phenylephrine-HCl Using Conductometric Titration Method. Curr Anal Chem [Internet]. 2016 Jul 1;12(4):330–4. Available from: .
13. Rocha JRC, Galhardo CX, Natividade MAE, Masini JC. Spectrophotometric Determination of Phenylephrine Hydrochloride in Pharmaceuticals by Flow Injection Analysis Exploiting the Reaction with Potassium Ferricyanide and 4-Aminoantipyrine. J AOAC Int [Internet]. 2002 Jul 1 [cited 2023 Jul 12];85(4):875–8. Available from: .
14. Al-Abachi MQ, Subhi S. Flow injection-Spectrophotometric Determination of Phenylephrine Hydrochloride and Amoxicillin Trihydrate in Pharmaceutical Preparations. J Al-Nahrain Univ Sci [Internet]. 2013 Mar 1;16(1):42–52. Available from: .
15. Wadher SJ, Kalyankar TM, Panchal PP. Development and Validation of Simultaneous Estimation of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in Bulk and Capsule Dosage Form by Ultra-Violet Spectrophotometry. Int J ChemTech Res CODEN( USA [Internet]. 2013;5(5):2410–9. Available from: .
16. Kazak Sarılmışer H, Özçelik NO, Özkırım Arslan B, Gökalp M, Ustaoğlu A, Dude UK, et al. Development and validation of a simple HPLC assay method for ibuprofen, pseudoephedrine hydrochloride and chlorpheniramine maleate in syrup form. J Chem Metrol [Internet]. 2017 Nov 2;11(2):61–7. Available from: .
17. Habibi B, Jahanbakhshi M. Simultaneous Determination of Ascorbic Acid, Paracetamol and Phenylephrine: Carbon Nanotubes Ceramic Electrode as a Renewable Electrode. Anal Bioanal Electrochem [Internet]. 2015;7(1):45–58. Available from: .
18. Aljeboree AM, Alshirifi AN. Determination of phenylephrine hydrochloride and Amoxicillin in binary mixture using Derivative Spectrophotometry methods. Int J Pharm Qual Assur [Internet]. 2019 Aug 30;10(03):168–77. Available from: .
19. Hasan S, Othman N, Surchi K. Using of Diazotized 2,4-Dinitroaniline in Spectrophotometric Estimation of Phenylephrine Hydrochloride. Rafidain J Sci [Internet]. 2020 Sep 2;29(3):37–46. Available from: .
20. Al-Sabha TN. Spectrophotometric Assay of Phenylephrine Hydrochloride Using 4-Aminoantipyrine and Copper (II). Pakistan J Anal Environ Chem [Internet]. 2010;11(1):1–7. Available from: .
21. Othman NS, Abdul Fatah NT. Spectrophotometric Determination of Phenylephrine Hydrochloride by Coupling with Diazotized 2-Aminobenzothiazole. Rafidain J Sci [Internet]. 2009;20(4):69–81. Available from: .
22. Mzban Q, Bahjat S, Hassan MJM. Dispersive liquid-liquid microextraction and spectrophotometric determination of cefazone and phenylephrine hydrochloride in their pure forms and pharmaceutical preparations. Plant Arch [Internet]. 2020;20(2):6771–7. Available from: .
23. Al-Uzri WA. Determination of phenylephrine hydrochloride in pharmaceutical preparations using spectro-photometric method. Asian J Pharm Clin Res [Internet]. 2019 Apr 9;12(5):339–43. Available from: .
24. Alteemi HS, Kadim KH. Colorimetric Determination of Phenylephrine hydrochloride Drug by Diazotization Reaction. J Phys Conf Ser [Internet]. 2020 Nov 1;1664(1):012097. Available from: .
25. Aljeboree AM, Alshirifi AN. Colorimetric Determination of phenylephrine hydrochloride drug Using 4-Aminoantipyrine: Stability and higher sensitivity. J Pharm Sci Res [Internet]. 2018;10(7):1774–9. Available from: .
26. Radia ND, Alshamusi QKM, Sahib IJ, Jasim LS, Aljeboree AM, Alkaim AF. Oxidative coupling of phenylephrine hydrochloride using N,N-dimethyl-p-phenylenediamine: Stability and higher sensitivity. In: AIP Conference Proceedings [Internet]. American Institute of Physics Inc.; 2022. p. 030026. Available from: .
27. Ahmed AMK, Anwar SM, Hattab AH. Spectrophotometric Determination of Phenylephrine Hydrochloride in Pharmaceutical Preparations by Oxidative Coupling Reaction. Int J Drug Deliv Technol [Internet]. 2020 Sep 25;10(03):323–7. Available from: .
28. Aljeboree AM, Alshirifi AN, Abdulrazzak FH, Abbas AS, Alkaim AF. Colorimetric Determination of pharmaceutical dyes Using 4-Aminoantipyrine : Oxidative coupling review. J Pharm Sci Res [Internet]. 2019;11(3):912–8. Available from: .
29. Battu S, Gandu V, Nenavathu BP. Simple spectrophotometric method for estimation of drugs using chloraminet and indigo caramine dye couple. Asian J Biomed Pharm Sci [Internet]. 2020;10(69):19–24. Available from: .
30. Zakaria SA. Simple spectrophotometric method for determination of phenylephrine hydrochloride in pure and pharmaceutical forms. Iraqi Natl J Chem [Internet]. 2021;20(1):1–11. Available from: .
31. Code CS. SECOND YEAR (2017-2018 onwards) THIRD SEMESTER THEORY.
32. Booth PM. FDA implementation of standards developed by the international conference on harmonisation. Food Drug Law J [Internet]. 1997;52(2):203–23. Available from: .
33. Sinnema A. Structure Elucidation by NMR in Organic Chemistry E. [Internet]. Vol. 112, Recueil des Travaux Chimiques des Pays-Bas. 1993. 650 p. Available from: .