Development and validation of spectrophotometric method for phenylephrine hydrochloride estimation in nasal drops formulations

Authors

  • Ivana Savić Faculty of Technology, University of Niš, Bulevar oslobodjenja 124, Leskovac
  • Goran Nikolić Faculty of Technology, University of Niš, Bulevar oslobodjenja 124, Leskovac
  • Vladimir Banković Pharmaceutical and Chemical Industry Zdravlje – Actavis, Vlajkova 199, Leskovac

DOI:

https://doi.org/10.20450/mjcce.2008.235

Keywords:

phenylephrine hydrochloride, spectrophotometry, nasal drops

Abstract

Simple, accurate and reproducible UV-spectrophotometric method was developed and validated for the estimation of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. Phenylephrine hydrochloride was estimated at 291 nm in 1 mol⋅dm-3 sodium hydroxide (pH 13.5). Beer’s law was obeyed in the concentration range of 10–100 μg⋅cm−3 (r2 = 0.9990) in the sodium hydroxide medium. The apparent molar absorptivity was found to be 1.63×103 dm3⋅mol−1⋅cm−1. The method was tested and validated for various parameters according to the ICH (International Conference on Harmonization) guidelines. The detection and quantitation limits were found to be 0.892 and 2.969 μg⋅cm−3, respectively. The proposed method was successfully applied for the determination of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 1 %), while being simple, cheap and less time consuming, and hence can be suitably applied for the estimation of phenylephrine hydrochloride in different dosage forms.

References

The Pharmaceutical Society of Great Britain, The Pharmaceutical Codex, 11th ed., The Pharmaceutical Press, London, 1979, pp. 695.

European Pharmacopoeia, Third edition, Council of Europe, Strasbourg, 1996.

A. Goth, Medical Pharmacology Principle and Concepts, 10th ed., The Mosby C.V. Company, 1981.

M. Knochen, J. Giglio, Flow-injection determination of phenylephrine hydrochloride in pharmaceutical dosage forms with on-line solid-phase extraction and spectrophotometric detection phenylephrine hydrochloride and orphenadrine citrate in pure and in dosage forms, Talanta 64 (5),1226–1232 (2004).

S. A. Shama, Spectrophotometric determination of J. Pharm. Biomed. Anal. 30,1385–1392 (2002).

P. Solich, C. K. Polydorou, M. A. Koupparis, C. E. Efstathiou,Automated flow-injection spectrophotometric determination of catecholamines (epinephrine and isoproterenol) in pharmaceutical formulations based on ferrous complex formation, J. Pharm. Biomed. Anal. 22 (5), 781–789 (2000).

N. Erk, Quatitative analysis of chlorpheniramine maleate and phenylephrine hydrochloride in nasal drops by differential- derivative spectrophotometric, zero-crossing first UV spectrophotometric and apsorbance ratio methods, J. Pharm. Biomed. Anal. 23, 1023–1031 (2000).

M. S. Collado, V. E. Mantovani, H. C. Goicoechea, A. C. Olivieri, Simultaneous spectrophotometric-multivariate calibration determination of several components of opthhalmic solutions: phenylephrine, chloramphenical, antipyrine, methylparaben and thimerasal, Talanta 52, 909–920 (2000).

I. S. Ahmed, A. S. Amin, Spectrophotometric microdetermination of phenylephrine hydrochloride in pure pharmaceutical formulations using haematoxylin, J. Molecul. Liq. 130, 84–87 (2007).

M. A. Martin, B. del Castillo, P. Prados,13-Hydrohaycena phato

,2-b]quinoliuivs bromide as a new fluorescence indicator, Talanta 40 (11), 1719–1723 (1993).

J. O. De Beer, C. V. Vandenbroucke, D. L. Massart, Experimental design for the rapid selectio of separation conditiones for methyl and propyl parahydroxybeyoate, phenylephrine hydrochloride and chlorphenamine maleate by ion-pair liquid chromatography, J. Pharm. Biomed. Anal. 12, 1379–1369 (1994).

N. Okamura, H. Miki, T. Harada, S. Yamаshita, Y. Masaoka, Y. Nakamoto, M. Tsuguma, H. Yoshitomi, A. Yagi, Simultaneous determination of ephedrine, pseudoephedrine, norephedrine and methylenphedrine in Kampo medicines by high-performance liquid chromatography, J. Pharm. Biomed. Anal. 20, 363–372 (1999).

A. Marin, E. Garcia, A. Garcia, C. Barbas, Validation of a HPLC quantification of acetaminophen, phenylephrine and chlorphenitamine in pharmaceutical formulations: capsules and sachets, J. Pharm. Biomed. Anal. 29, 701– 714. (2002).

B. Olmo, A. Garcıa, A. Marın, C. Barbas, New approaches with two cyano columens to the separation of acetaminophen, phenylephrine, chlorpheniramine and related compounds, J. Chromatogr. B 817, 159–165 (2005).

M. J. Galmier, A. M. Frasey, S. Meski, E. Beyssac, J. Petit, J. M. Aiache, C. Lartigue, High-performance liquid chromatographic determination of phenylephrine and tropicamide in human aqueous humor, Biomed. Chromatogr. 14, 202–204 (2000).

N. Erk, M. Kartal, Simultaneous high performance liquid chromatographic and derivative ratio spectra spectrophotometry determination of chloropheniramine maleate and phenylephrine hydrochloride, Il Farmaco, 53, 617– 622 (1998).

M. Gil-Agusti, L. Monferrer-Pons, M. Celia Garcia-Alvarez- Coque, J. Esteve-Romero, Determination of active ingredients in cough-cold preparations by micellar liquid chromatography, Talanta 54, 621–630 (2001).

J. Maria Lemus Gallego, J. Perez Arroyo, Determination of prednisolone, naphazoline and phenylephrine in local pharmaceutical preparations by micellar electrouiretic chromatography, J. Sep. Sci. 26, 947–952 (2003).

A. Marın, C. Barbas, CE versus HPLC for the dissolution test in a pharmaceutical formulation containing acetaminophen, phenylephrine and chlorpheniramine, J. Pharm. Biomed. Anal. 35, 769–777 (2004).

Z. Wang, Y. L. Sun, Z. P. Sun, Enantiomeric separation of amphetamine and phenylephrine by cyclodextrinmediated capillary zone electrophoresis, J. Chromatogr. A, 735, 295–314 (1996).

S. M. Sabry, M. H. Abdel-Hay, M. H. Barary, T. S. Belal, Sensitive spectrofluorometric and spectrophotometric methods for the determination of thonzylamine hydrochloride in pharmaceutical preparations based oncoupling with dimethylbarbituric acid presenc of aircyclohexylcarbamide, J. Pharm. Biomed. Anal. 22, 257–266 (2000).

The European Agency for the Evaluation of Medicinal Products, ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95, 1996.

United States Pharmacopoeia, Validation of Compendial Methods, 26th edition, Pharmacopoeial Convention Inc., Rockville, MD, 2003, pp. 2439–2442.

Jugoslovenska pharmacopoeia, 5th edition, Savremena administracija, Beograd (2000).

S. Bolton, Pharmaceutical Statistics: practical and clinical application, 3rd ed., Marcel Dekker, New York, 1997, pp. 216–264.

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Published

2008-12-15

How to Cite

Savić, I., Nikolić, G., & Banković, V. (2008). Development and validation of spectrophotometric method for phenylephrine hydrochloride estimation in nasal drops formulations. Macedonian Journal of Chemistry and Chemical Engineering, 27(2), 149–156. https://doi.org/10.20450/mjcce.2008.235

Issue

Vol. 27 No. 2 (2008)

Section

Analytical Chemistry

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