Abstract
Accurate, precise, and sensitive UPLC method was developed and validated for the simultaneous determination of a quaternary mixture containing guaiphenesin (GUP), oxeladin citrate (OXC), diphenhydramine (DPH), and sodium benzoate (SOB) in the presence of GUP-related substance, guaiacol (GUA). Chromatographic separation was achieved using NUCLEOSHELL® column—C18 (4.0 × 50.0 mm, 2.7 μm). Isocratic elution at a flow rate 1.0 mL/min was performed using a mobile phase consisting of acetonitrile:phosphate buffer pH 3.5 ± 0.1 (25.0:75.0, v/v). The specificity of the developed method was investigated by analyzing of laboratory-prepared mixtures containing different ratios of the four drugs, in the presence of GUA as well as their combined pharmaceutical formulation. The obtained results were statistically compared with those obtained by the official or reported methods, showing no significant difference with respect to accuracy and precision at p = 0.05.
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Abdelwahab NS, Abdelaleem EA (2013) TLC-densitometric determination of guaifenesin, pseudoephedrine hydrochloride and guaifenesin related substance (guaiacol). J Planar Chromatogr Mod TLC 26:73–77. https://doi.org/10.1556/jpc.26.2013.1.11
Abdelwahab NS, Abdelaleem EA (2017) Stability indicating RP-HPLC method for simultaneous determination of guaifenesin and pseudoephedrine hydrochloride in the presence of syrup excepients. Arab J Chem 10:2896–2901. https://doi.org/10.1016/j.arabjc.2013.11.019
Ali NW, Abdelkawy M, Abdelhamid NS (2013) Determination of oxeladin citrate in the presence of two of its degradation products by HPTLC and HPLC. Int J Pharm Pharm Sci 5:282–289
Bambagiotti-Alberti M, Pinzauti S, Vincieri FF (1986) Simultaneous capillary gas chromatographic determination of guaifenesin, dextromethorphan and diphenhydramine in cough-cold syrup. Pharm Acta Helv 62:175–176
Boukarim C, Jaoudé SA, Bahnam R, Barada R, Kyriacos S (2009) Preservatives in liquid pharmaceutical preparations. J Appl Res 9:14–17. https://doi.org/10.1002/dta.28
Darwish HW, Metwally FH, Bayoumi A (2014a) Simultaneous spectrophotometric determination of diphenhydramine benzonatate, guaifenesin and phenylephrine in their quaternary mixture using partial least squares with and without genetic algorithm as a powerful variable selection procedure digest. J Nanomater Biostruct 9:1359–1372
Darwish HW, Metwally FH, El Bayoumi A, Ashour AA (2014b) Artificial neural networks and concentration residual augmented classical least squares for the simultaneous determination of diphenhydramine, benzonatate, guaifenesin and phenylephrine in their quaternary mixture. Trop J Pharm Res 13:2083–2090
Donmez OA, Asci B, Bozdogan A, Sungur S (2011) 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 83:1601–1605. https://doi.org/10.1016/j.talanta.2010.11.054
El-Gindy A (2005) High performance liquid chromatographic determination of oxeladin citrate and oxybutynin hydrochloride and their degradation products. Il Farmaco 60:689–699. https://doi.org/10.1016/j.farmac.2005.06.001
European Pharmacopoeia (Ph. Eur.) (2012) Council of Europe. Strasbourg, France
Farid NF, El Ragehy NA, Hegazy MA, Abdelkawy M, Metwally FH (2014) Simultaneous determination of a quaternary mixture of oxomemazine, sodium benzoate, guaifenesin and paracetamol by chromatographic methods. Beni-Suef Univ J Basic Appl Sci 3:260–268. https://doi.org/10.1016/j.bjbas.2014.11.006
Galli V, Barbas C (2004) High-performance liquid chromatographic analysis of dextromethorphan, guaifenesin and benzoate in a cough syrup for stability testing. J Chromatogr A 1048:207–211. https://doi.org/10.1016/j.chroma.2004.07.050
Grosa G, Del Grosso E, Russo R, Allegrone G (2006) Simultaneous, stability indicating HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. J Pharm Biomed Anal 41:798–803. https://doi.org/10.1016/j.jpba.2006.01.026
Gutman EB, Spatz H (1982) Alternative methods for determining different drugs in haematological specimens. SAFYBI 22:1752–1760
ICH Q2 (R1) (2003) Validation of analytical procedures. In: Proceeding the International Conference of Harmonization, Geneva
Khade V, Mirgane S (2014) High-performance liquid chromatography method for the analysis of sodium benzoate. Int J Sci Eng Res 5:1382–1384
Kishk SM, Salama I, Mostafa S, El-Sadek M (2014) Stability-indicating chromatographic method for the determination of benzoate diphenhydramine, guaifenesin, and phenylephrine. J Liq Chromatogr Relat Technol 37:726–747. https://doi.org/10.1080/10826076.2012.758140
Knopp C, Korsatko W (1982) Determination of oxeladin citrate in drug combinations. Pharmazie 37:76–77
Lartigue-Mattei C, Galmier MJ, Chabard JL, Beyssac E, Aiache JM (1995) Determination of oxeladin in human plasma by gas chromatography—mass spectrometry. Biomed Chromatogr 9:32–35
Lin YT, Kou HS, Wu HL (2008) A simple micellar electrokinetic capillary chromatographic method for the quantitative analysis of organic expectorants. Electrophoresis 29:3524–3530. https://doi.org/10.1002/elps.200800129
Mohamed FA, Mohamed AI, Mohamed HA, Hussein SA (1996) Utility of quercetin for determination of some tertiary amine and quaternary ammonium salts. Talanta 43:1931–1939. https://doi.org/10.1016/0039-9140(96)01979-0
Naguib IA, Abdelaleem EA, Farag SA, Zaazaa HE (2017) Simultaneous determination of guaifenesin, salbutamol sulfate or dextromethorphan HBr and guaifenesin impurity (Guaiacol) by HPTLC. Method Anal Chem Lett 7:142–152. https://doi.org/10.1080/22297928.2017.1325778
Novakova L, Matysova L, Solich P (2006) Advantages of application of UPLC in pharmaceutical analysis. Talanta 68:908–918. https://doi.org/10.1016/j.talanta.2005.06.035
Reddy T, Balammal G, Kumar A (2012) Ultra performance liquid chromatography: an introduction and review. Int J Pharm Res Anal 2:24–31
Remington JP (2006) Remington: the science and practice of pharmacy, vol 1. Lippincott Williams & Wilkins, Philadelphia
United States Pharmacopeial Convention (2009) USP 32 NF 27: United States pharmacopeia and National formulary, Supplement 1. United States Pharmacopeial Convention, Rockville, MD
Salvesen B, Haugland T (1981) Determination of oxeladin in human sera by gas–liquid chromatography with thermionic detection. J Chromatogr B Biomed Sci Appl 225:463–468
Samatha Y, Srividya A, Ajitha A, Rao VU (2015) Ultra performance liquid chromatography (UPLC). World J Pharm Pharm Sci 4:356–367
Schieffer GW, Hughes DE (1983) Simultaneous stability-indicating determination of phenylephrine hydrochloride, phenylpropanolamine hydrochloride, and guaifenesin in dosage forms by reversed-phase paired-ion high-performance liquid chromatography. J Pharm Sci 72:55–59
Sweetman SC (2011) Martindale: the complete drug reference, vol A. 37 edn. Pharmaceutical Press, London, p 1701
The British Pharmacopoeia (2016) Her majesty’s stationary office, London
Turak F, Guzel R, Dinc E (2015) A new UPLC approach for the simultaneous quantitative estimation of four compounds in a cough syrup formulation. J Chromatogr Sci 54:28–35. https://doi.org/10.1093/chromsci/bmv102
Food and Drug Administration (FDA) (1994) Department of Health and Human Services. Center for Drug Evaluation and Research (CDER). Reviewer Guidance: validation of chromatographic methods. https://www.fda.gov/downloads/drugs/guidances/ucm134409.pdf
Vasudevan M, Ravisankar S, Sathiyanarayanan A, Chandan RS (2000) Simultaneous estimation of phenylpropanolamine HCl, guaiphenesin and diphenylpyraline HCl in syrups by LC. J Pharm Biomed Anal 24:25–31. https://doi.org/10.1016/s0731-7085(00)00385-x
Zayed SI, Issa YM (2013) Plastic membrane, carbon paste and multiwalled carbon nanotube composite coated copper wire sensors for determination of oxeladin citrate using batch and flow injection techniques. J Braz Chem Soc 24:585–594. https://doi.org/10.5935/0103-5053.20130069
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Merey, H.A., Ramadan, N.K., Diab, S.S. et al. Validated UPLC method for the determination of guaiphenesin, oxeladin citrate, diphenhydramine, and sodium benzoate in their quaternary mixture used in treatment of cough, in the presence of guaiphenesin-related substance (guaiacol). Chem. Pap. 72, 2247–2254 (2018). https://doi.org/10.1007/s11696-018-0454-2
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DOI: https://doi.org/10.1007/s11696-018-0454-2