DETERMINATION OF PHENYLEPHRINE HYDROCHLORIDE IN PHARMACEUTICAL PREPARATIONS USING SPECTROPHOTOMETRIC METHOD

  • WASAN A AL-UZRI Department of Chemistry, College of Science, University of Baghdad, Jadriyah, Baghdad, Iraq.

Abstract

Objective: A simple and sensitive spectrophotometric method has been presented for the determination of phenylephrine hydrochloride by coupling reaction with diazotized sulfacetamide sodium.


Methods: The method is based on the diazotization reaction of sulfacetamide sodium with sodium nitrite in the presence of hydrochloric acid to form diazonium salt, which is coupled with the drug in alkaline medium to form azo dye, showing absorption maxima at 425 nm.


Results: Calibration plot was linear over the concentration range of 2–24 μg/mL and detection limit of 0.278 μg/mL with a correlation coefficient of 0.9929. All different chemical and physical experimental parameters affecting on the development and stability of the colored product were carefully studied.


Conclusions: The proposed method was successfully applied to the determination of phenylephrine in nasal drops with good precision and sensitivity.

Keywords: Phenylephrine hydrochloride, Spectrophotometric determination, Sulfacetamide sodium, Diazotization and coupling.

References

1. Council of Europe. European Pharmacopoeia. 3rd ed. Strasbourg: Council of Europe; 1996.
2. The Stationery Office. British Pharmacopoeia on CD-ROM. 3rd ed. London: System Simulation Ltd., The Stationery Office; 2000.
3. Goodman A, Rall T, Nier A, Taylor P. The Pharmacology Bases of Therepeutics. New York: McGraw-Hill; 1996.
4. H.M. Stationary Office. British Pharmacopaeia. London: H.M. Stationary Office; 2001.
5. Goth A. Medical Pharmacology Principle and Concepts. 10th ed. St. Louis, MO: The Mosby C.V. Company; 1981.
6. Hasan SH, Othman NS, Surchi KM. Determination of phenylephrine-HCl using conductometric titration method. Curr Anal Chem 2016;12:330-4.
7. 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 2018;54:741-6.
8. Huang F, Jin G, Liu Y, Kong J. Sensitive determination of phenylephrine and chlorprothixene at poly(4-aminobenzene sulfonic acid) modified glassy carbon electrode. Talanta 2008;74:1435-41.
9. Pourghobadi Z, Niazi A. Voltametric study and determination of phenylephrine hydrochloride at INP-Nafion-modified CPE sensor employing differential pulse voltammetry. J Pure Appl Chem 2014;30:219-27.
10. Hegazy MA, Al-Ghobashy MA, Eltanany BM, Khattab FI. Purity indicating TLC method for quantitative determination of phenylephrine and dimethin dine maleate in presence of dimethin dine maleate impurity: 2-ethyl pyridine in nasal gel. J Pharm Res 2016;1:1-6.
11. Bandelwar R, Nikam A, Sawant S. Analytical method development and validation of phenylephrine hydrochloride, chlorpheniramine maleate, paracetamol and caffeine in bulk drug and tablet dosage form by RP-HPLC. Indo Am J Pharm Res 2013;3:4330-8.
12. Dewani AP, Dabhade SM, Bakal RL, Gadewar CK, Chandewar AV, Patra AV. Development and validation of a novel RP-HPLC method for simultaneous determination of paracetamol, phenylephrine hydrochloride, caffeine, cetirizine and nimesulide in tablet formulation. Arab J Chem 2015;8:591-8.
13. Michal D, Petr G. Fast HPLC method using ion-pair and hydrophilic interaction liquid chromatography for determination of phenylephrine in pharmaceutical formulations. J AOAC Int 2010;93:1436-42.
14. Patel DM, Chaudhary AB, Patel BD. Development and validation of RP-HPLC method for simultanous estimation of beclomethasone dipropionate, phenylephrine hydrochloride and lignocaine hydrochloride in cream. World J Pharm Pharm Sci 2018;7:829-41.
15. Al-Abachi MQ, Abed SS. Flow injection-spectrophotometric determination of phenylephrine hydrochloride and amoxicillin trihydrate in pharmaceutical preparations. J Al-Nahrain Univ 2013;16:42-52.
16. Rocha JR, Galhardo CX, Natividade MA, 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 2002;85:875-8.
17. Mestre YF, Zamora YF, Lahuerta L, Martínez CJ. Determination of phenylephrine hydrochloride by flow injection analysis with chemiluminescence detection. J AOAC Int 2001;84:13-8.
18. Salem YA, Hammouda ME, Abu El-Enin MA, El-Ashry SM. Application of derivative emission fluorescence spectroscopy for determination of ibuprofen and phenylephrine simultaneously in tablets and biological fluids. Spectrochim Acta A Mol Biomol Spectrosc 2019;210:387-97.
19. Fawzy MA, Ekram AE, Essam MH, Mohamed FK, Hamdy MA. Spectrophotometric analysis of two eye preparations, vial and drops, containing ketorolac tromethamine and phenylephrine hydrochloride binary mixture and their ternary mixture with chlorphenirmaine maleate. Bull Fac Pharm Cairo Univ 2018;56:91-100.
20. Al-Sabha TN. Spectrophotometric assay of phenylephrine hydrochloride using 4-aminoantipyrine and copper (II). Pak J Anal Environ Chem 2010;11:1-7.
21. Ahmed IS, Amin AS. Spectrophotometric microdetermination of phenylephrine hydrochloride in pure and in pharmaceutical formulations using haematoxylin. J Mol Liq 2007;130:84-7.
22. Al-Abachi MQ, Abed SS. Spectrophotometric determination of phenylephrine hydrochloride and salbutamol sulphate drugs in pharmaceutical preparations using diazotized metoclopramide hydrochloride. Baghdad Sci J 2015;12:167-77.
23. Savi? I, Nikoli? G, Bankovi? V. Development and validation of spectrophotometric method for phenylephrine estimation in nasal drops formulations. J Chem Chem Eng 2008;27:149-56.
24. Othman NS, Fatah NT. Indirect spectrophotometric determination of phenylephrine hydrochloride in pharmaceutical preparations. Tikrit J Pure Sci 2011;16:74-82.
25. Habibur R. Utilization of eosin dye as an ion pairing agent for determination of pharmaceuticals: A brief review. Int J Pharm Pharm Sci 2017;9:1.
26. Sharma DK, Jasvir S, Pushap R. Spectrophotometric determination of propranolo hydrochloride and metopranol tartrate in pharmaceutical dosage forms, spiked water and biological fluids. Int J Pharm Pharm Sci 2018;10:107.
27. Al-Abachi MQ, Al-Ghabsha TS. Fundamentals of Analytical Chemistry. Mosul: Press of Mosul University; 1983.
28. Sanders DH, Murph AF. Statistics. New York: McGraw-Hill; 1976.
29. System Simulation Ltd., the Stationary Office. British Pharmacopeia on CD-ROM. London: System Simulation Ltd., the Stationary Office; 2005.
30. De-Levie R. Principles of Quantitative Chemical Analysis. Singapore: The McGraw-Hill Companies, Inc.; 1997. p. 221.
31. H.M. Stationary Office. British Pharmacopaeia. London: H.M. Stationary Office; 2007.
32. Miller JN, Miller JC. Statistics and Chemometrics for Analytical Chemistry. 4th ed. London: Pearson Education Limited; 2000.
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How to Cite
WASAN A AL-UZRI. “DETERMINATION OF PHENYLEPHRINE HYDROCHLORIDE IN PHARMACEUTICAL PREPARATIONS USING SPECTROPHOTOMETRIC METHOD”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 5, Apr. 2019, pp. 339-43, https://innovareacademics.in/journals/index.php/ajpcr/article/view/32339.
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