Login Register Cart 0
Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Novel Rapid Isocratic RP-HPLC Method for Simultaneous Estimation of Phenylephrine Hydrochloride, Paracetamol, Caffeine, Diphenhydramine Hydrochloride

Author(s): Revati Sonone, Leena Tandel and Vandana Jain*

Volume 17, Issue 6, 2021

Published on: 30 April, 2020

Page: [792 - 800] Pages: 9

DOI: 10.2174/1573412916999200430091855

Price: $65

Abstract

Background: A tablet dosage form widely used in the treatment of cough and cold, containing phenylephrine hydrochloride, paracetamol, caffeine, and diphenhydramine hydrochloride as active pharmaceutical ingredient was selected for the development of a novel, rapid, simultaneous isocratic reversed phase-high performance liquid chromatography (RP-HPLC) method.

Objective: The objective of this paper was to develop and validate a novel, rapid, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of phenylephrine hydrochloride, paracetamol, caffeine, diphenhydramine hydrochloride in bulk and pharmaceutical dosage form.

Method: Optimized chromatographic conditions were an isocratic elution with prontosil C18-column (250×4.6 mm, 5 μ), methanol and 20mM phosphate buffer (55:45 v/v, pH 3 ) as mobile phase, flow rate 1.0 mL/min and UV detector set at λ max 220 nm. The method was validated for specificity, precision, linearity, accuracy, sensitivity, and robustness as per the International Council for Harmonization guidelines.

Result: The retention times of phenylephrine hydrochloride, paracetamol, caffeine, diphenhydramine hydrochloride were found to be 2.8 min, 3.3 min, and 4.0 min and 7.3 min, respectively. This novel method was found to be rapid, simple, linear (R2> 0.99), preciserelative standard deviation < 2.0 %), accurate (recovery 98-102%), sensitive and robust.

Conclusion: The proposed novel isocratic RP-HPLC method is rapid (short run time below 10min), highly selective, precise, accurate, sensitive and robust. The method was successfully applied for the simultaneous analysis of phenylephrine hydrochloride, paracetamol, caffeine, diphenhydramine hydrochloride in a pharmaceutical dosage form.

Keywords: Phenylephrine hydrochloride, paracetamol, caffeine, diphenhydramine hydrochloride, HPLC, drugs.

« Previous Next »
Graphical Abstract

[1]
Eccles, R. Substitution of phenylephrine for pseudoephedrine as a nasal decongeststant. An illogical way to control methamphetamine abuse. Br. J. Clin. Pharmacol., 2007, 63(1), 10-14.
[http://dx.doi.org/10.1111/j.1365-2125.2006.02833.x] [PMID: 17116124]
[2]
Graham, G.G.; Scott, K.F. Mechanisms of action of paracetamol and related analgesics. Inflammopharmacology, 2003, 11(4), 401-413.
[http://dx.doi.org/10.1163/156856003322699573] [PMID: 15035793]
[3]
Nehlig, A.; Daval, J.L.; Debry, G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res. Brain Res. Rev., 1992, 17(2), 139-170.
[http://dx.doi.org/10.1016/0165-0173(92)90012-B] [PMID: 1356551]
[4]
Mohammed, A.B.; Gunasekar, M. Simultaneous estimation of diphenhydramine hydrochloride and naproxen sodium in raw and tablet formulation by reverse- phase high performance liquid chromatographic method. Int. Res. J. Pure Appl. Chem., 2016, 13(2), 2231-3443.
[5]
Senyuva, H.; Özden, T. Simultaneous high-performance liquid chromatographic determination of paracetamol, phenylephrine HCl, and chlorpheniramine maleate in pharmaceutical dosage forms. J. Chromatogr. Sci., 2002, 40(2), 97-100.
[http://dx.doi.org/10.1093/chromsci/40.2.97] [PMID: 11881712]
[6]
Harahap, Y.; Puspasari, M.O. Development of a high- performance liquid chromatography method for the simultaneous analysis of theophylline, guaifenesin and diphenhydramine in an elixir. Trop. J. Pharm. Res., 2017, 16(10), 2501-2506.
[7]
Acheampong, A.; Gyasi, W.O.; Darko, G.; Apau, J.; Addai-Arhin, S. Validated RP-HPLC method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation. Springerplus, 2016, 5(1), 625.
[http://dx.doi.org/10.1186/s40064-016-2241-2] [PMID: 27330891]
[8]
Dönmez, O.A.; Aşçi, B.; Bozdoğan, A.; Sungur, S. Simultaneous determination of potassium guaiacolsulfonate, guaifenesin, diphenhydramine HCl and carbetapentane citrate in syrups by using HPLC-DAD coupled with partial least squares multivariate calibration. Talanta, 2011, 83(5), 1601-1605.
[http://dx.doi.org/10.1016/j.talanta.2010.11.054] [PMID: 21238758]
[9]
Sanchaniya, P.M.; Mehta, F.A.; Uchadadiya, N.V. Development and validation of an RP-HPLC method for estimation of chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride in combined pharmaceutical dosage form. Chromatogr. Res. Int., 2013, 1-6.
[http://dx.doi.org/10.1155/2013/424865]
[10]
Bachute, M.T. Method development and validation by RP-HPLC for simultaneous estimation of Paracetamol, caffeine, phenylephrine and chlorpheniramine in tablet dosage form. Int. J. Pharm. Technol., 2017, 9(2), 29960-29970.
[11]
Kumar, A.; Sharma, R.; Nair, A.; Saini, G. Development and validation of RP-HPLC method for simultaneous estimation of nimesulide, phenylephrine hydrochloride, chlorpheniramine maleate and caffeine anhydrous in pharmaceutical dosage form. Acta Pol. Pharm., 2012, 69(6), 1017-1022.
[PMID: 23285660]
[12]
Pirol, O.; Sukuroglu, M.; Ozden, T. Simultaneous determination of paracetamol, phenylephrine hydrochloride, oxolamine citrate and chlorpheniramine maleate by HPLC in pharmaceutical dosage forms. E-J. Chem., 2011, 8(3), 1275-1279.
[http://dx.doi.org/10.1155/2011/454325]
[13]
International conference on harmonization of technical requirements for registration of pharmaceuticals of human use. Validation of analytical procedures: Text and methodology ICH Q2 (R1). 2005.

Rights & Permissions Print Cite
Article Metrics
25
1
© 2024 Bentham Science Publishers | Privacy Policy