CHARGE TRANSFER SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF TWO ANTIHISTAMINIC DRUGS IN PHARMACEUTICAL FORMULATIONS
Keywords:
Desloratadine, Ebastine, Charge transfer complexes, Spectrophotometry, Pharmaceutical formulationsAbstract
Objective: Simple, accurate and precise spectrophotometric methods have been developed for the determination of two antihistaminic drugs (desloratadine (DES) and ebastine (EBS)) in pure forms and pharmaceutical formulations.
Methods: The proposed methods were based on the charge transfer complexation reaction of both drugs as ‘n' electron donor with chloranilic acid (p-CLA) or 2, 3-Dichloro-5,6-dicyano-p-benzoquinone (DDQ) as π acceptors to give highly coloured complex species. The coloured products were quantitated spectrophotometrically at 459 and 460 nm using DDQ and at 532 and 533 nm using p-CLA for DES and EBS, respectively. Optimization of the different experimental conditions were studied.
Results: Beer's law was obeyed in the concentration ranges of 5.0-120 and 10-180 mg mL-1 with good correlation coefficients were ≥ 0.9995 and 0.9992 and a relative standard deviation (R.S.D.) of ≤ 0.98 and 1.24% using DDQ and p-CLA methods, respectively. The molar absorptivity, Sandell's sensitivity, detection and quantification limits were also calculated. The developed methods were successfully applied for determination of the studied drugs in pharmaceutical formulations with good accuracy and precision and without interferences from common additives by applying the standard addition technique.
Conclusion: The developed methods have been validated statistically for their accuracy, precision, sensitivity, selectivity, robustness and ruggedness as per ICH guidelines and the results compared favorably with those obtained using the reported methods.
Downloads
References
Sweetman SC. Martindale the Complete Drug Reference, 36th ed., The Pharmaceutical Press, London, 2009;p. 576-79.
British Pharmacopoeia, Her, Majesty's Stationary Office, London;2012;Vol. I:p. 2173-76.
Johnson R, Christensen J, Lin C. Sensitive gas-liquid chromatographic method for the determination of loratadine and its major active metabolite, descarboethoxyloratadine, in human plasma using a nitrogen-phosphorus detector, J Chromatogr B Biomed Appl 1994;657:125-31.
Zhang D, Blume H. HPLC determination of loratadine and its active metabolite descarboethoxyloratadine in human plasma. J Pharmazie 1994;49:736-9.
Yin OOP, Shi X, Chow MSS. Reliable and specific high-performance liquid chromatographic method for simultaneous determination of loratadine and its metabolite in human plasma, J Chromatogr B 2004;796:165-72.
Liu L, 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.
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-Enany N, EL-Sherbiny D, Belal F. Spectrophotometric, spectrofluorometric and HPLC determination of desloratadine in dosage forms and human plasma. J Chem Pharm Bull 2007;55:1662-70.
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.
Zheng J, Rustum AM. Rapid separation of desloratadine and related compounds in solid pharmaceutical formulation using gradient ion-pair chromatography, J Pharm Biomed Anal 2010;51:146-52.
Patel RB, Patel MR, Mehta JB. Validation of stability indicating high performance liquid chromatographic method for estimation of desloratadine in tablet formulation. Arabian J Chem 2012.
Yang L, Clement RP, Kantesaria B, Reyderman L, Beaudry F, Grandmaison C, Di Donato L et al. Validation of a sensitive and automated 96-well solid-phase extraction liquid chromatography-tandem mass spectrometry method for the determination of desloratadine and 3-hydroxydesloratadine in human plasma. J Chromatogr B 2003;792:229-40.
Srinubabu G, Patel RS, Shedbalkar VP, Rao AA, Rao MN, Bandaru VV. Development and validation of high-throughput liquid chromatography-tandem mass spectrometric method for simultaneous quantification of loratadine and desloratadine in human plasma. J Chromatogr B 2007;860:202-08.
Shen JX, Wang H, Tadros S, Hayes RN. J Pharm Biomed Anal 2006;40:689-06.
Kubacak P, Mikus P, Valaskova I, Havranck E. Isotachophoretic determination of desloratadine in tablets and syrup. J Ceska Slov Farm 2005;54:266-9.
Rao DD, Satyanarayana NV, Reddy AM, Sait SS, Chakole D, Mukkanti KA. validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms. J Pharm Biomed Anal 2010;51:736-42.
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. J Luminescence 2011;26:670-9.
Raviteja KH, Nasare M, Prasad VVLN, Diwan PV. UV pectrophotometric method for the simultaneous determination of desloratidine and pseudoephedrine HCl in combined dosage form. British J Pharm Res 2014;4:418-28.
Patel JM, Talele GS, Fursule RA. Spectrophotometric determination of desloratidine in bulk and tablets form. Asian J Chem 2004;16:1220-2.
Bondili S, Reddy SP. Spectroscopic method for determination of desloratadine in bulk and its tablet dosage forms. Int J Pharm Ind Res 2011;1:131-4.
Abd El-Hay SS, El-Mammli MY, Shalaby AA. Determination of clemastine hydrogen fumarate, desloratadine, losartan potassium and moxepril HCl through binary complex formation with eosin. Arabian J Chem 2011.
Mohamed GG, Abou Attia FM, Ismail NS, Ibrahim NS. Analytical uses of charge-transfer complexes:determination of dosage forms of desloratadine. J Acta Pharm Sciencia 2011;53:89-98.
Cağlar S, Oztunç AA. sensitive spectrophotometric determination of desloradine in tablets. J AOAC Int 2007;90:372-5.
Rele Rajan V, Gurav Pankaj J. A simple extractive spectrophotometric determination of loratadine, desloratadine and rupatadine from pharmaceutical formulations. Int J Pharma Bio Sci 2012;3:89-95.
Gouda AA, Kassem M. Novel spectrophotometric methods for determination of desloratidine in pharmaceutical formulations based on charge transfer reaction. Arabian J Chem 2012.
Patel JM, Talele GS, Furule RA, Surana SJ. Extractive spectrophotometric determination of desloratadine from its bulk and pharmaceutical dosage form. J Indian Drugs 2006;43:507-9.
Rani EM, Ahad HA, Sreenivasulu R, Rani M, Giri M, Reddy BKK, Kranthi G. Spectrophotometric determination of desloratadine in pharmaceuticals by using difference spectrophotometric method. J Pharm Res 2011;4:730-4.
Matsuda M, Mizuki Y, Terauchi Y. Simultaneous determination of the histamine H1 receptor antagonist ebastine and its two metabolites, carebastine and hydroxyl ebastine in human plasma using high performance liquid chromatography. J Chromatogr B 2001;757:173-9.
Kang W, Liu KH, Ryu JY, Shin J G. Simultaneous determination of ebastine and its three metabolites in plasma using liquid chromatography-tandem mass spectrometry. J Chromatogr B 2004;813:75–80.
Ashok P, Meyyanathan SN, Pandilla B, Suresh B. Analysis of ebastine in pharmaceutical preparations by high-performance thin-layer chromatography. J Planar Chromatogr 2003;16:167-9.
Prabhu SL, Dinesh kumar C, Shirwakar A, Shirwakar A. Determination of ebastine in pharmaceutical formulations by HPLC. Ind J Pharm Sci 2008;70:406-07.
Sunitha PG, Vaidhyalingam V, Shantha A, Ezhil Muthu RP. Development and validation of HPLC and HPTLC methods for quantification of ebastine in tablets Indian Drugs 2004; 41:149-51.
Ibrahim F, Sharaf El-Din MK, Eid MI, Wahba MEK. Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization:Application to tablets and content uniformity testing. J Chem Central 2011;5:1-15.
Wagh RS, Hajare RA, Tated A, Chandewar AV. Absorption correction method and simultaneous Equation method for the simultaneous estimation of ebastine and phenylephrine hydrochloride in Bulk and in combined tablet dosage form. Int J Res Pharm Chem 2011;1:812-819.
Wagh RS, Hajare RA, Tated AG, Gadbail PA, Khan FA, Kayal SD. Method development and validation for simultaneous determination of ebastine and phenylepherine in tablet formulation by RP-HPLC. Int J Pharm Res Develop 2011;3:214-20.
Schmidt AH, Molnar I. Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations. J Pharm Biomed Anal 2013;78–79:65–74.
Nelofer SM, Janardhan M. Analytical method development and validation for the assay of ebastine in ebastine mouth dissolving tablets. Int J Pharm Clin Res 2012;4:56-60
Sreedhar NY, Sreenivasulu A, Sunil Kumar M, Nagaraju M. Electrochemical determination of ebastine in tablet dosage forms at hanging mercury drop electrode. Int J Pharm Tech Res 2012;4:1303-08.
Ibrahim F, Sharaf El-Din MK, Eid MI, Wahba MEK. Validated stability-indicating spectrofluorimetric methods for the determination of ebastine in pharmaceutical preparations. J Chem Central 2011;5:1-14.
Sharaf El-Din MF, Ibrahim F, Eid MI, Wahba MEK. Validated spectroflurimetric determination of some H1 receptor antagonist drugs in pharmaceutical preparations through charge transfer complexation. J Fluoresc 2012;22:75-91.
Ibrahim F, Sharaf El-Din MK, Eid M, Wahba MEK. Spectrophotometric determination of some H1 receptor anatagonist drugs in pharmaceutical formulations and biological fluids. Int J Pharm Sci Res 2011;2:2056-72.
Soni LK, Narsinghani T, Saxena C. Development and validation of UV spectrophotometric assay protocol for simultaneous estimation of ebastine and phenylephrine hydrochloride in tablet dosage form using simultaneous equation method. Int J Chem Tech Res 2011;3:1918-25.
Savsani JJ, Goti PP. Development and validation of simultaneous equation method for estimation of ebastine and montelukast sodium in combined tablet dosage form. Der Pharmacia Sinica 2012;3:690-8.
Jangid RK, Magdum CS. Development and validation of UV spectrophotometric method for simultaneous estimation of ebastine and montelukast sodium in bulk and marketed dosage form. Int J Pharm Res Develop 2013;5:51-56.
Sudhakar DM, Kumar JH, Namdeorao G K. Development and validation of UV spectrophotometric estimation of ebastine in bulk and tablet dosage form using area under curve method Int. Res J Pharm 2013;4:201-04.
El-Kommos ME, El-Gizawy SM, Atia NN, Hosny NM. Spectrophotometric determination of some non-sedating antihistamines using erythrosine B. Anal Chem 2013;ID 209518:1-9.
Savsani JJ, Goti PP, Patel PB. Simultaneous UV Spectrophotometric method For estimation of ebastine and montelukast sodium in tablet dosage form by Q-ratio method. Int J Chem Tech Res 2013;5:47-55.
Soni LK, Narsinghani T, Saxena C. UV-Spectrophotometric estimation of ebastine and phenylephrine hydrochloride in tablet dosage form using absorption ratio method. Der Pharmacia Sinica 2011;2:11-16.
Sunitha PG, Niralmathi V, Aruna A, Vaidhyalingam V, Shantha A. Spectrophotometric methods for the determination of ebastine in tablets. Indian drugs 2003;40:577-9.
Foster R. Organic Charge Transfer Complexes. Academic Press, London. 1969;51.
Gouda AA, EL-Sheikh R, Amin AS. J Chem Pharm Bull 2008;56:34-40.
Gouda AA. J Talanta 2009;80:151–57.
Gouda AA, Amin AS, Youssef EH. Spectrophotometric methods based on charge transfer complexation reactions for the determination of amisulpride in pure form and pharmaceutical formulations. IJPPS 2014;6:154-60.
Gouda AA, Al Malah Z. Development and validation of sensitive spectrophotometric method for determination of two antiepileptics in pharmaceutical formulations. Spectrochim Acta A 2013;105:488–96.
El Sheikh R, Gouda AA, El-Azzazy R. Spectrophotometric study on the charge transfer complex between sumatriptan succinate and some π-acceptors and alizarin derivatives. J CICEQ 2013;19:529−40.
Job P. Anal. Chem, 1936;16, 97, In, "Advanced Physicochemical Experiments". 2nd edition. Oliner and Boyd, Edinburgh;1964;P. 54.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures:Text and Methodology Q2(R 1), Complementary Guideline on Methodology. J London November 2005.
Mendham J, Denney RC, Barnes JD, Thomas M. Vogel’s Textbook of Quantitative Chemical Analysis, Pearson Education Ltd, England, 2000.
Ringbom A. "Accuracy of calorimetric determinations". J Anal Chem 1939;115:332-43.
Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry†5th ed., Prentice Hall, England, 2005.