EXTRACTIVE SPECTROPHOTOMETRIC DETERMINATION OF SOME ANTIHISTAMINIC DRUGS FROM PHARMACEUTICAL FORMULATIONS USING ROSE BENGAL

Authors

  • Akram M. El-didamony Faculty of Science, Zagazig University, Zagazig, EGYPT
  • Sameh M. Hafeez Ismailia Chemical Laboratory

Keywords:

Desloratadine, Chlorpheniramine maleate, Diphenhydramine hydrochloride, Fexofenadine, Rose Bengal, Ion-pair complexes, Spectrophotometry

Abstract

Objective: Simple and sensitive an extractive-spectrophotometric method have been developed for the determination of four important antihistaminic drugs, namely desloratadine (DSL), chlorpheniramine maleate (CPM), diphenhydramine hydrochloride (DPH) and fexofenadine (FXO).

Methods: This method is based on the formation of colored ion-pair complexes between the basic nitrogen of the drugs and halofluorescein dyes, namely rose bengal (RB) dye in weak acidic medium. The formed complexes were extracted with dichloromethane measured spectrophotometrically at 550 nm.

Results: The reaction conditions were optimized to obtain the maximum color intensity. Beer's law was obeyed with a good correlation coefficient (0.9963-0.9975) in the concentration ranges 1-6, 4-18, 6-16 and 2-22 µg/ml for DSL, CPM, DPH and FXO, respectively. The composition ratio of the ion-pair complexes was found to be 1:1 as established by Job's method.

Conclusion: The proposed method was successfully extended to pharmaceutical preparations. Excipients used as additive in commercial formulations did not interfere in the analysis. The proposed method can be recommended for quality control and routine analysis where time, cost effectiveness and high specificity of analytical technique are of great importance.

 

Downloads

Download data is not yet available.

References

Kleemann A, Engels J. Encyclopedia of Pharmaceutical Substances,†4th ed. Pdf; 2000.

Graul A, Leeson PA, Castaner J. Sitaxsentan sodium. Endothelin ET(A) antagonist treatment of heart failure treatment of pulmonary hypertension. Drug Future 2000;25:339-46.

Day JH, Briscoe MP, Clark RH, Ellis AK, Gervais P. Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis. Ann Allergy Asthma Immunol 1997;79:163-72.

Qi M, Wang P, Geng Y. Determination of desloratadine in drug substances and pharmaceutical preparations by liquid chromatography. J Pharm Biomed Anal 2005;38:355–9.

El-Sherbiny DT, El-Enany N, Belal FF, Hansen SH. Simultaneous determination of loratadine and desloratadine in pharmaceutical preparations using liquid chromatography with microemulsion as eluent. J Pharm Biomed Anal 2007;43:1236–42.

Shen JX, Xu Y, Tama CI, Merka EA, Clement RP. Simultaneous determination of desloratadine and pseudoephedrine in human plasma using micro-solid-phase extraction tips and aqueous normal-phase liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom 2007;21:3145–55.

Liu LL, Qi M, Wang P, Li H. High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs. J Pharm Biomed Anal 2004;34:1013–9.

El-Enany N, El-Sherbiny D, Belal F. Spectrophotometric, spectrofluorometric and HPLC determination of desloratadine in dosage forms and human plasma. Chem Pharm Bull 2007;55:1662–70.

Walash MI, Belal F, El-Enany N, Eid M, El-Shaheny RN. Stability-indicating micelle-enhanced spectrofluorimetric method for the determination of loratadine and desloratadine in dosage forms. Luminescence 2011;26:670–9.

Patel JM, Talele GS, Fursule RA. Spectrophotometric determination of desloratidine in bulk and tablets form. Asian J Chem 2004;16:1220-2.

Patel JM, Talele GS, Furule RA, Surana SJ. Extractive spectrophotometric determination of desloratadine from its bulk and pharmaceutical dosage form. Indian Drugs 2006;43:507.

Cağlar S, Oztunç A. Sensitive spectrophotometric method for the determination of desloratadine in tablets. J AOAC Int 2007;90:372-5.

Howland R, Mycek M. Lippincott's Illustrated Reviews: Pharmacology. 4th Edition Lippincott Williams & Wilkins; 2009.

Algaba C, Saldaña J, Camañas R, Sagrado S, Hernánde M. Analysis of pharmaceutical preparations containing antihistamine drugs by micellar liquid chromatography. J Pharm Biomed Anal 2006;40:312-21.

Romero J, Broch S, Agustí M, Peiró M, Bose D. Micellar liquid chromatography for the determination of drug materials in pharmaceutical preparations and biological samples. TrAC Trends Anal Chem 2005;24:75-91.

Zhao S, Li D, Qiu J, Wang M, Yang S, Chen D. Simultaneous determination of amantadine, rimantadine and chlorpheniramine in animal derived food by liquid chromatography-tandem mass spectrometry after fast sample preparation. Anal Methods 2014;6:7062–7.

Heydari R. A new HPLC method for the simultaneous determination of acetaminophen, phenylephrine, dextromethorphan and chlorpheniramine in pharmaceutical formulations. Anal Lett 2008;41:965–76.

Lou H, Yuan H, Ruan Z, Jiang B. Simultaneous determination of paracetamol, pseudoephedrine, dextrophan and chlorpheniramine in human plasma by liquid chromatography–tandem mass spectrometry. J Chromatogr B 2010;878:682–8.

Vignaduzzo SE, Kaufman TS. Development and validation of a HPLC method for the simultaneous determination of bromhexine, chlorpheniramine, paracetamol, and pseudoephedrine in their combined cold medicine formulations. J Liq Chromatogr RT 2013;36:2829–43.

Qi ML, Wang P, Leng YX, Gu JL, Fu RN. Simple HPLC method for simultaneous determination of acetaminophen, caffeine and chlorpheniramine maleate in tablet formulations. Chromatographia 2002;56:295-8.

Al-Rimawi F. Normal-phase LC method for simultaneous analysis of pseudophedrine hydrochloride, dextromethorphan hydrobromide, chlorpheniramine maleate, and paracetamol in tablet formulations. Saudi Pharm J 2010;18:103-6.

Gómez M, Avies M, Sagrado S, Camañ R, Hernández M. Characterization of antihistamine–human serum protein interactions by capillary electrophoresis. J Chromatogr A 2007;1147:261–9.

Al-Shaalan NH. Determination of phenylephrine hydrochloride and chlorpheniramine maleate in binary mixture using chemometric-assisted spectrophotometric and high-performance liquid chromatographic-UV methods. J Saudi Chem Soc 2010;14:15–21.

Kazemipour M, Ansari M. Derivative spectrophotometry for simultaneous analysis of chlorpheniramine maleate, phenylephrine HCl and phenylpropanolamine HCl in ternary mixtures and pharmaceutical dosage forms. Iran J Pharm Res 2005;3:147-53.

Erk N. Quantitative analysis of chlorpheniramine maleate and phenylephrine hydrochloride in nasal drops by differential-derivative spectrophotometric zero-crossing first derivative UV spectrophotometric and absorbance ratio methods. J Pharm Biomed Anal 2000;23:1023-31.

Kaura AK, Gupta V, Kaura M, Roy GS, Bansal P. Spectrophotometric determination of chlorpheniramine maleate and phenylpropanolamine hydrochloride by two wavelengths method. J Pharm Res 2013;7:404-8.

Suliman F, Al-Hinai M, Al-Kindy S, Salama S. Chemiluminescence determination of chlorpheniramine using tris(1,10-phenanthroline)–ruthenium(II)peroxydisulphate system and sequential injection analysis. Luminescence 2009;24:2–9.

Pojanagaroon T, Liawruangrath S, Liawruangrath B. A direct current polarographic method for the determination of chlorpheniramine maleate in pharmaceutical preparations. Chiang Mai J Sci 2007;34:135-42.

Abu-Shawish H. Potentiometric response of modified carbon paste electrode based on mixed ion–exchangers. Electroanalysis 2008;20:491–7.

El-Gindy A, Emaraa S, Mostafa A. Application and validation of chemometrics-assisted spectrophotometry and liquid chromatography for the simultaneous determination of six-component pharmaceuticals. J Pharm Biomed Anal 2006;41:421–30.

Goicoechea HC, Olivieri AC. Chemometric assisted simultaneous spectrophotometric determination of four-component nasal solutions with a reduced number of calibration samples. Anal Chim Acta 2002;453:289-300.

Basavaiah K, Charan VS. Titrimetric and spectrophotometric assay of some antihistamines through the determination of the chloride of their hydrochlorides. IL Farmaco 2002;57:9-17.

Hassan WS, El-Henawee MM, Gouda AA. Spectrophotometric determination of some histamine H1-antagonists drugs in their pharmaceutical preparations. Spectrochim Acta A 2008;69:245-55.

Ulu ST, Elmali FT. Spectrophotometric method for the determination, validation, spectroscopic and thermal analysis of diphenhydramine in pharmaceutical preparation. Spectrochim Acta A 2010;77:324-9.

Tipparat P, Lapanantnoppakhum S, Jakmunee J, Grudpan K. Determination of diphenhydramine hydrochloride in some single tertiary alkylamine pharmaceutical preparations by flow injection spectrophotometry. J Pharm Biomed Anal 2002;30:105–12.

Sumandeep R, Garg RK, Singla A. Rapid analysis of urinary opiates using fast gas chromatography–mass spectrometry and hydrogen as a carrier gas. Egypt J Forensic Sci 2014;4:100-7.

El Ries MA, Khalil S. Indirect atomic absorption determination of atropine, diphenhydramine, tolazoline, and levamisole based on formation of ion-associates with potassium tetraiodometrcurate. J Pharm Biomed Anal 2001;25:3-7.

Donmez OA, Ascı B, Bozdoǵan 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;83:1601–5.

Wang C, Fan G, Lin M, Chen Y, Zhao W, Wu Y. Development and validation of a liquid chromatography/tandem mass spectrometry assay for the simultaneous determination of D-amphetamine and diphenhydramine in beagle dog plasma and its application to a pharmacokinetic study. J Chromatogr B-Anal Technol Biomed Life Sci 2007;854:48-56.

Gomez MR, Sombra L, Olsina RA, Martínez LD, Silva MF. Development and validation of a capillary electrophoresis method for the determination of codeine, diphenhydramine, ephedrine and noscapine in pharmaceuticals. IL Farmaco 2005;60:85-90.

Liu JF, Cao WD, Yang XR. Determination of diphenhydramine by capillary electrophoresis with tris(2,20-bipyridyl)ruthenium(II) electrochemiluminescence detection. Talanta 2003;59:453–9.

Marchesini AF, Williner MR, Mantovani VE, Robles JC, Goicoechea HC. Simultaneous determination of naphazoline, diphenhydramine and phenylephrine in nasal solutions by capillary electrophoresis. J Pharm Biomed Anal 2003;31:39-46.

The Merck Index, an encyclopedia of chemicals, drugs and biologicals. Merck & Co, Inc, Whitehouse Station, NJ; 2001.

Simpson K, Jarvis B. Fexofenadine: a review of its use in the management of seasonal allergic rhinitis and chronic idiopathic urticaria. Drugs 2000;59:301–21.

Breier AR, Paim SC, Menegola J, Steppe M, Schapoval EE. Development and validation of a liquid chromatographic method for fexofenadine hydrochloride in capsules. J AOAC Int 2004;87:1093–7.

Maher HM, Sultan MA, Olah IV. Development of validated stability-indicating chromatographic method for the determination of fexofenadine hydrochloride and its related impurities in pharmaceutical tablets. Chem Cent J 2011;5:76.

Arayne MS, Sultana N, Shehnaz H, Haider A. RP-HPLC method for the quantitative determination of fexofenadine hydrochloride in coated tablets and human serum. Med Chem Res 2011;20:55–61.

Miura M, Uno T, Tateishi T, Suzuki T. Determination of fexofenadine enantiomers in human plasma with high performance liquid chromatography. J Pharm Biomed Anal 2007;43:741–5.

Yamane N, Tozuka Z, Sugiyama Y, Tanimoto T, Yamazaki A, Kumagai Y. Microdose clinical trial: quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2007;858:118–28.

Arayne MS, Sultana N, Mirza AZ, Siddiqui FA. Simultaneous determination of gliquidone, fexofenadine, buclizine, and levocetirizine in dosage formulation and human serum by RP-HPLC. J Chromatogr Sci 2010;48:382–5.

Arayne MS, Sultana N, Shehnaz H, Haider A. RP-HPLC method for the quantitative determination of fexofenadine hydrochloride in coated tablets and human serum. Med Chem Res 2011;20:55–61.

Vekaria H, Limbasiya V, Patel P. Development and validation of RP-HPLC method for simultaneous estimation of montelukast sodium and fexofenadine hydrochloride in combined dosage form. J Pharm Res 2013;6:134–9.

Mahgoub H, Gazy AA, El-Yazbi FA, El-Sayed MA, Youssef RM. Spectrophotometric determination of binary mixtures of pseudoephedrine with some histamine H1-receptor antagonists using derivative ratio spectrum method. J Pharm Biomed Anal 2003;31:801–9.

Kumar KS, Ravichandran V, Raja MM, Thyagu R, Dharamsi A. Spectrophotometric determination of fexofenadine hydrochloride. Indian J Pharm Sci 2006;68:841–2.

Maggio RM, Castellano PM, Vignaduzzo SE, Kaufman TS. Alternative and improved method for the simultaneous determination of fexofenadine and pseudoephedrine in their combined tablet formulation. J Pharm Biomed Anal 2007;45:804–10.

Polawar PV, Shivhare UD, Bhusari KP, Mathur VB. Development and validation of spectrophotometric method of analysis for fexofenadine. Res J Pharm Technol 2008;1:539–41.

Vekaria HJ, Muralikrishna KS, Patel GF. Development and validation of spectrophotometric method for estimation of fexofenadine hydrochloride and montelukast sodium in combined dosage form. Pharm Anal Qual Assur 2011;4:197–9.

Ashour S, Khateeb M, Mahrouseh R. Extractive spectrophotometric and conductometric methods for determination of fexofenadine hydrochloride in pharmaceutical dosage forms. Pharm Anal Acta 2013;S2:1–6.

Abd El-Hay SS, Colyer CL, Hassan WS, Shalaby A. Spectrofluorimetric determination of etodolac, moxepril HCl and fexofenadine HCl using europium sensitized fluorescence in bulk and pharmaceutical preparations. J Fluoresc 2012;22:247–52.

Abbas MN, Fattah AA, Zahran E. A novel membrane sensor for histamine H1-receptor antagonist fexofenadine. Anal Sci 2004;20:1137–42.

Breier AR, Garcia SS, Jablonski A, Steppe M, Schapoval EES. Capillary electrophoresis method for fexofenadine hydrochloride in capsules. J AOAC Int 2005;88:1059–63.

Job P. Formation and stability of inorganic complexes in solution. Ann Chim 1928;9:113–23.

Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry. 5th ed. Prentice Hall, England; 2005.

Published

01-06-2015

How to Cite

El-didamony, A. M., and S. M. Hafeez. “EXTRACTIVE SPECTROPHOTOMETRIC DETERMINATION OF SOME ANTIHISTAMINIC DRUGS FROM PHARMACEUTICAL FORMULATIONS USING ROSE BENGAL”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 6, June 2015, pp. 152-7, https://mail.innovareacademics.in/journals/index.php/ijpps/article/view/5641.

Issue

Section

Original Article(s)