Sensitive Extractional Colorimetric Analysis of Fexofenadine Hydrochloride and Irbesartan Bases Through Acid-Dye Complexation Using Naphthol Blue Black in Pure Form and Pharmaceuticals
Modern Chemistry
Volume 5, Issue 6, December 2017, Pages: 93-100
Received: Jan. 25, 2017; Accepted: Feb. 10, 2017; Published: Nov. 28, 2017
Views 2034      Downloads 66
Authors
Safwan Ashour, Analytical Chemistry Laboratory, Department of Chemistry, Faculty of Sciences, University of Aleppo, Aleppo, Syria
Roula Bayram, Analytical Chemistry Laboratory, Department of Chemistry, Faculty of Sciences, University of Aleppo, Aleppo, Syria
Article Tools
Follow on us
Abstract
A simple, accurate and sensitive method has been presented for the determination of fexofenadine hydrochloride (FEX) and irbesartan (IRB) in bulk and pharmaceutical preparations. The method is based on the reaction of the above cited drugs with naphthol blue black (NBB) dye in solutions containing Britton buffer to form ion-pair complexes extractable with chloroform and subsequently measured spectrophotometrically at 625 nm. All the reaction conditions for the proposed methods have been studied. The reactions were extremely rapid at room temperature and the absorbance values remained unchanged for at least 24 hrs. Beer's law was obeyed in the concentration ranges 2.7–53.8 and 10–244 μg mL-1 with detection limit of 0.013 and 0.75 μg mL-1 for FEX and IRB, respectively. The proposed methods were applied successfully for the determination of FEX and IRB in pharmaceutical formulations. Interferences of the other ingredients and excipients were not observed. The results obtained were compared statistically with those obtained by the official method and showed no significant differences regarding accuracy and precision.
Keywords
Extractive Colorimetry, Fexofenadine Hydrochloride, Irbesartan, Naphthol Blue Black, Pharmaceuticals
To cite this article
Safwan Ashour, Roula Bayram, Sensitive Extractional Colorimetric Analysis of Fexofenadine Hydrochloride and Irbesartan Bases Through Acid-Dye Complexation Using Naphthol Blue Black in Pure Form and Pharmaceuticals, Modern Chemistry. Vol. 5, No. 6, 2017, pp. 93-100. doi: 10.11648/j.mc.20170506.12
Copyright
Copyright © 2017 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
References
[1]
Maryadele J, Neil JO, The Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, 15th ed., Royal Society of Chemistry, Cambridge, UK, 2013.
[2]
Rita Breier A, Nudelman NS, Steppe M, Schapoval EES, Isolation and structure elucidation of photodegradation products of fexofenadine. Journal of Pharmaceutical and Biomedical Analysis, 2008, 46, pp. 250–257.
[3]
British Pharmacopœia, Her Majesty Stationery Officer, London, UK, 2013.
[4]
United States Pharmacopoeial Convention Inc. Rockville, 2011.
[5]
Breier AR, Paim SC, Menegola J, Steppe M, Schapoval EE, Development and validation of a liquid chromatographic method for fexofenadine hydrochloride in capsules. Journal of AOAC International, 2004, 87 (5), pp. 1093–1097.
[6]
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. Chemistry Central Journal, 2011, 5 (76), pp. 1–10.
[7]
Arayne MS, Shehnaz H, Sultana N, Haider A, RP-HPLC method for the quantitative determination of fexofenadine hydrochloride in coated tablets and human serum. Medicinal Chemistry Research, 2011, 20 (1), pp. 55–61.
[8]
Kozan I, Palabiyik IM, Karacan E, Onur F, Spectrophotometric and high performance liquid chromatographic determination of fexofenadine hydrochloride in pharmaceutical formulations. Turkish Journal of Pharmaceutical Sciences, 2008, 5 (3), pp. 175–189.
[9]
Gazy AA, Mahgoub H, El-Yazbi FA, El-Sayed MA, Youssef RM, Determination of some histamine H1-receptor antagonists in dosage forms. Journal of Pharmaceutical and Biomedical Analysis, 2002, 30 (3), pp. 859–867.
[10]
Suresh Kumar K, Ravichandran V, Mohan Maruga Raja MK, Thyagu R, Dharamsi A, Spectrophotometric determination of fexofenadine hydrochloride. Indian Journal of Pharmaceutical Sciences, 2006, 68 (2), pp. 841–842.
[11]
Rajput SJ, Parekh PR, Spectrophotometric determination of fexofenadine hydrochloride in bulk drug and in its dosage form. Eastern Pharmacist, 2001, 44 (527), pp. 101-103.
[12]
Polawar PV, Shivhare UD, Bhusari KP, Mathur VB, Development and validation of spectrophotometric method of analysis for fexofenadine. Research Journal of Pharmacy and Technology, 2008, 1 (4), pp. 539–541.
[13]
Ashour S, Khateeb M, Mahrouseh R, Extractive spectrophotometric and conductometric methods for determination of fexofenadine hydrochloride in pharmaceutical dosage forms. Pharmaceutica Analytica Acta, 2013, S2, pp. 1–6.
[14]
Amin AS, Ahmed IS, Mohamed HA, Utility of extracted colored ion–associate complexes formation reaction for the determination of fexofenadine hydrochloride in pure forms and in dosage forms. Journal of Chemical Engineering & Process Technology, 2010, 1 (1), pp. 1–4.
[15]
Alothman ZA, Bukhari N, Haider S, Wabaidur SM, Alwarthan AA, Spectrofluorimetric determination of fexofenadine hydrochloride in pharmaceutical preparation using silver nanoparticles. Arabian Journal of Chemistry, 2010, 3 (4), pp. 251–255.
[16]
Abbas MN, Abdel Fattah AA, Zahran E, A novel membrane sensor for histamine H1-receptor antagonist fexofenadine. Analytical Sciences, 2004, 20 (8), pp. 1137–1142.
[17]
Mikuš P, Valášková I, Havránek F, Determination of fexofenadine in tablets by capillary electrophoresis in free solution and in solution with cyclodextrins as analyte carriers. Drug Development and Industrial Pharmacy, 2005, 31 (8), pp. 795–801.
[18]
Breier AR, Garcia SS, Jablonski A, Steppe M, Schapoval EES, Capillary electrophoresis method for fexofenadine hydrochloride in capsules. Journal of AOAC International, 2005, 88 (4), pp. 1059–1063.
[19]
Zarapkar SS, Bhandari NP, Halkar UP, Simultaneous determination of fexofenadine hydrochloride and pseudoephedrine sulfate in pharmaceutical dosage by reverse phase high performance liquid chromatography. Indian Drugs, 2000, 37 (9), pp. 421–425.
[20]
Radhakrishna T, Reddy GO, Simultaneous determination of fexofenadine and its related compounds by HPLC. Journal of Pharmaceutical and Biomedical Analysis, 2002, 29 (4), pp. 681–690.
[21]
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. Journal of Pharmaceutical Research, 2013, 6 (1), pp. 134–139.
[22]
Karakuş S, Küçükgüzel İ, Güniz Küçükgüzel Ş, Development and validation of a rapid RP-HPLC method for the determination of cetirizine or fexofenadine with pseudoephedrine in binary pharmaceutical dosage forms. Journal of Pharmaceutical and Biomedical Analysis, 2008, 46 (2), pp. 295–302.
[23]
Arayne MS, Sultana N, Zeeshan MA, Siddiqui FA, Simultaneous determination of gliquidone, fexofenadine, buclizine, and levocetirizine in dosage formulation and human serum by RP-HPLC. Journal of Chromatographic Sciences, 2010, 48 (5), pp. 382–385.
[24]
Tandulwadkar SS, More SJ, Rathore AS, Nikam AR, Sathiyanarayanan L, Kakasaheb R, Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium in drug formulation using normal phase high-performance thin-layer chromatography. ISRN Analytical Chemistry, 2012, pp. 1–7.
[25]
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. Journal of Pharmaceutical and Biomedical Analysis, 2003, 31 (4), pp. 801–809.
[26]
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. Journal of Pharmaceutical and Biomedical Analysis, 2007, 45 (5), pp. 804–810.
[27]
Vekaria HJ, Muralikrishna KS, Patel GF, Development and validation of spectrophotometric method for estimation of fexofenadine hydrochloride and montelukast sodium in combined dosage form. Pharmaceutical Analysis & Quality Assurance, 2011, 4, pp. 197–199.
[28]
Li JM, Wu Q, Wang LL, Assay of irbesartan tablets by HPLC. Yaowu Fenxi Zazhi, 2001, 21 (4), pp. 249–250.
[29]
Goswami N, A validated stability-indicating liquid chromatographic method for determination of process related impurities and degradation behavior of irbesartan in solid oral dosage. Journal of Advanced Pharmaceutical Technology & Research, 2014, 5 (1), pp. 33–40.
[30]
Ganesan M, Nanjundan S, Gomathi M, Muralidharan S, Method development and validation of irbesartan using LCMS/MS: Application to pharmacokinetic studies. Journal of Chemical and Pharmaceutical Research, 2010, 2, pp. 740–746.
[31]
Praveen KM, Sreeramulu J, Development and validation of a stability-indicating RP-HPLC method for assay of irbesartan in pure and pharmaceutical dosage form. International Journal of Pharmaceutical Sciences Review and Research, 2011, 6 (10), pp. 94–99.
[32]
Mbah CJ, Kinetics of decomposition of irbesartan in aqueous solutions determined by high performance liquid chromatography. Pharmazie, 2004, 29 (12), pp. 920–922.
[33]
Abdellatef HE, Extractive-spectrophotometric determination of disopyramide and irbesartan in their pharmaceutical formulation. Spectrochimica Acta Part A, 2007, 66 (4–5), pp. 1248-1254.
[34]
Rahman N, Siddiqui MR, Azmi SNH, Quantitative analysis of irbesartan in commercial dosage forms by kinetic spectrophotometry. Chemical and Pharmaceutical Bulletin, 2006, 54 (5), pp. 626–631.
[35]
Ganesh K, Balraj C, Elango KP, Spectroscopic and spectrofluorimetric studies on the interaction of irbesartan with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone and iodine. Spectrochimica Acta Part A, 2011, 79 (5), pp. 1621–1629.
[36]
Kulsum S, Padmalatha M, Kumar E, Sruthi M, Vidyasagar G, Spectrophotometric methods for the determination of irbesartan in pure and pharmaceutical dosage forms. Research Journal of Pharmacy and Technology, 2011, 4 (10), pp. 1567–1569.
[37]
Sane RT, Francis M, Pawar S, Determination of irbesartan in pharmaceutical dosage forms by HPTLC. Indian Drugs, 2002, 39 (1), pp. 32–35.
[38]
Alanazi AM, Abdelhameed AS, Khalil NY, Khan AA, Darwish IA, HPLC method with monolithic column for simultaneous determination of irbesartan and hydrochlorothiazide in tablets. Acta Pharmaceutica, 2014, 64 (2), pp. 187–198.
[39]
Hafez HM, Elshanawane AA, Abdelaziz LM, Kamal MM, Quantitative determination of three angiotensin-II-receptor antagonists in presence of hydrochlorothiazide by RP-HPLC in their tablet preparations. Iranian Journal of Pharmaceutical Research, 2013, 12 (4), pp. 635–43.
[40]
Ebeid WM, Elkady EF, El-Zaher AA, El-Bagary RI, Patonay G, Synchronized separation of seven medications representing most commonly prescribed antihypertensive classes by using reversed-phase liquid chromatography: Application for analysis in their combined formulations. Journal of Separation Science, 2014, 37 (7), pp. 748–757.
[41]
Pachauri S, Paliwal S, Srinivas KS, Singh Y, Jain V, Development and validation of HPLC method for analysis of some antihypertensive agents in their pharmaceutical dosage forms. Journal of Pharmaceutical Sciences and Research, 2010, 2, pp. 459–464.
[42]
Rane VP, Patil KR, Sangshetti JN, Yeole RD, Shinde DB, Stability indicating LC method for simultaneous determination of irbesartan and hydrochlorothiazide in pharmaceutical preparations. Journal of Chromatographic Science, 2010, 48 (7), pp. 595–600.
[43]
Sultana N, Arayne MS, Ali SS, Sajid S, Simultaneous determination of olmesartan medoxomil and irbesartan and hydrochlorothiazide in pharmaceutical formulations and human serum using high performance liquid chromatography. Se Pu, 2008, 26 (5), pp. 544–549.
[44]
Ramzia IEB, Hanaa MH, Waleed AE, Spectrofluorometric, spectrophotometric and LC determination of irbesartan. Journal of Chemical and Pharmaceutical Research, 2011, 3, pp. 722–733.
[45]
Vujić Z, Mulavdić N, Smajić M, Brborić J, Stankovic P, Simultaneous analysis of irbesartan and hydrochlorothiazide: an improved HPLC method with the aid of a chemometric protocol. Molecules, 2012, 17, pp. 3461–3474.
[46]
Vetuschi C, Giannandrea A, Carlucci G, Mazzeo P, Determination of hydrochlorothiazide and irbesartan in pharmaceuticals by fourth-order UV derivative spectrophotometry. IL Farmaco, 2005, 60 (8), pp. 665–670.
[47]
Erk N, Three new spectrophotometric methods applied to the simultaneous determination of hydrochlorothiazide and irbesartan. Pharmazie, 2003, 58 (8), pp. 543–548.
[48]
Albero I, Ródenas V, García S, Sánchez-Pedreño C, Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry. Journal of Pharmaceutical and Biomedical Analysis, 2002, 29 (1-2), pp. 299–305.
[49]
Fayez YM, Simultaneous determination of some anti-hypertensive drugs in their binary mixture by novel spectrophotometric methods. Spectrochimica Acta Part A, 2014, 132, pp. 446–451.
[50]
Joseph Charles J, Brault S, Boyer C, Langlois MH, Cabrero L, Dubost JP, Simultaneous determination of irbesartan and hydrochlorothiazide in tablets by derivative spectrophotometry. Analytical Letters, 2003, 36 (11), pp. 2485–2495.
[51]
Hillaert S, Van-den-Bossche W, Simultaneous determination of hydrochlorothiazide and several angiotensin-II-receptor antagonists by capillary electrophoresis. Journal of Pharmaceutical and Biomedical Analysis, 2003, 31 (2), pp. 329–339.
[52]
Hillaert S, Van den Bossche W, Optimization and validation of a capillary zone electrophoretic method for the analysis of several angiotensin-II-receptor antagonists. Journal of Chromatography A, 2002, 979 (1-2), pp. 323–333.
[53]
Ashour S, Shehna MF, Bayram R, Spectrophotometric determination of alfuzosin HCl in pharmaceutical formulations with some sulphonephthalein dyes. International Journal of Biomedical Science, 2006, 2 (3), pp. 273–278.
[54]
Ashour S, Alkhalil R, Simple extractive colorimetric determination of levofloxacin by acid-dye complexation methods in pharmaceutical preparations. IL Farmaco, 2005; 60, pp. 771–775.
[55]
Sastry CSP, Rama Rao K, Siva Prasad D, Extractive spectrophotometric determination of some fluoroquinolone derivatives in pure and dosage forms. Talanta, 1995, 42, pp. 311–316.
[56]
Rose J, Advanced physico-chemical experiments, Pittman, London, 1964, 67.
[57]
Erk N, Extractive spectrophotometric methods for the novel antidepressant drug in bulk and pharmaceutical dosage forms by using bromthymol blue and bromcresol green. Analytical Letters, 2003, 36, pp. 1183–1196.
[58]
Miller JN, Miller JC, Statistics and Chemometrics For Analytical Chemistry, Chapman & Hall/CRC, London, UK, 5th edition, 2005.
[59]
Long GL, Winefordner JD, Limit of detection. a closer look at the IUPAC definition. Analytical Chemistry, 1983, 55 (7), pp. 712A–721A.
[60]
Ringbom A, Zeitschrift Analytische Chemie, 1939, pp. 115–332.
ADDRESS
Science Publishing Group
548 FASHION AVENUE
NEW YORK, NY 10018
U.S.A.
Tel: (001)347-688-8931