Analytical methods for determination of terbinafine hydrochloride in pharmaceuticals and biological materials

The Merck Index, 14th Edition, Merck & Co., Inc., Whitehouse Station, N.J, 2006, Monograph No. 0009156. Gokhale, 2000, Understanding the antifungal activity of Terbinafine analogues using quantitative structure-activity relationship (QSAR) models, Bioorg. Med. Chem., 8, 2487, 10.1016/S0968-0896(00)00178-4 Web of informations database, Charles University, 2004. 〈http://bi.cuni.cz〉 Gupta, 2003, Superficial fungal infections: an update on pityriasisversicolor, seborrheic dermatitis, tineacapitis, and onychomycosis, Clin. Dermatol., 21, 417, 10.1016/j.clindermatol.2003.08.003 Healthwise® for every health decision®, Terbinafine, 2004. 〈http://health.yahoo.com/topic/skinconditions/medications/drug/healthwise/d04012a1〉 European Pharmacopoeia, EDQM, Council of Europe, Strasbourg, France, Edition 7.0, 2011, pp. 3047–3048. British Pharmacopoeia, Her Majesty's, Stationery office, London, 2012, pp. 2112–2113. United States Pharmacopoeia, USP35, National Formulary-32, Rockville, USP Convention, 2012, pp. 4789–4790. Cardoso, 1999, UV spectrophotometry and nonaqueous determination of Terbinafine hydrochloride in dosage forms, J. AOAC Int., 82, 830, 10.1093/jaoac/82.4.830 Goswami, 2013, Development and validation of spectrophotometric method for the determination of Terbinafine hydrochloride in bulk and in tablet dosage form, Int. J. Pharm. Technol., 5, 5441 Patel, 2012, Spectrophotometric determination and validation for Terbinafine hydrochloride in pure and in tablet dosage form, Pharm. Lett., 4, 1119 Penmatsa, 2013, Stability indicating UV-spectrophotometric assay of Terbinafine hydrochloride in dosage forms, Int. J. ChemTech Res., 5, 2645 Goswami, 2013, Validated spectrophotometric method for the estimation of Terbinafine hydrochloride in bulk and in tablet dosage form using inorganic solvent, Pharm. Lett., 5, 386 Jain, 2011, Development and validation of the UV-spectrophotometric method for the determination of Terbinafine hydrochloride in bulk and in formulation, Pharm. Methods, 2, 198, 10.4103/2229-4708.90364 Abdel-Moety, 2002, Spectrophotometric determination of Terbinafine in presence of its photodegradation products, Bull. Chim. Farm., 141, 267 El-Saharty, 2002, Simultaneous determination of Terbinafine HCl and Triamcinolone acetonide by UV derivative spectrophotometry and spectrodensitometry, J. Pharm. Biomed. Anal., 28, 569, 10.1016/S0731-7085(01)00692-6 Florea, 2008, Spectrophotometric determination of Terbinafine through ion-pair complex formation with methyl orange, Farmacia, 56, 393 Elazazy, 2008, Application of certain ion - pairing reagents for extractive spectrophotometric determination of Flunarizine hydrochloride, Ramipril, and Terbinafine hydrochloride, Biosci. Biotechnol. Res. Asia, 5, 107 Chennaiah, 2012, Extractive spectrophotometric methods for determination of Terbinafine hydrochloride in pharmaceutical formulations using some acidic triphenylmethane dyes, Indian J. Chem. Technol., 19, 218 Mrutyunjayarao, 2012, Three simple spectrometric determination of Terbinafine hydrochloride (TRB) in pure state and tablets, Proc. Natl. Acad. Sci. India A, 82, 221 Karuna, 2006, Spectrophotometric determination of drugs with iodine, J. Sci. Ind. Res., 65, 808 Belal, 2013, Spectrofluorimetric determination of Terbinafine hydrochloride and Linezolid in their dosage forms and human plasma, J. Fluoresc., 23, 1077, 10.1007/s10895-013-1237-3 Mielech-Lukasiewicz, 2014, Comparison of boron-doped diamond and glassy carbon electrodes for determination of Terbinafine in pharmaceuticals using differential pulse and square wave voltammetry, Anal. Lett., 47, 1697, 10.1080/00032719.2014.883518 Faridbod, 2013, Potentiometric PVC membrane sensor for the determination of Terbinafine, Int. J. Electrochem. Sci., 8, 6107, 10.1016/S1452-3981(23)14745-6 Samy, 2005, Conductimetric determination of cyproheptadine, Cetirizine, and Terbinafine hydrochlorides through the formation of ion-associates with manganese and zinc thiocyanate complexes, J. Drug Res., 26, 139 Arranz, 1997, Voltammetric behaviour of the antimycotic Terbinafine at the hanging drop mercury electrode, Anal. Chim. Acta, 351, 97, 10.1016/S0003-2670(97)00350-4 Tagliari, 2010, Terbinafine: optimization of a LC method for quantitative analysis in pharmaceutical formulations and its application for a tablet dissolution test, Quim. Nova, 33, 1790, 10.1590/S0100-40422010000800029 Florea, 2009, Determination of Terbinafine hydrochloride by ion-pair reversed phase liquid chromatography, Farmacia, 57, 82 Gopal, 2008, Reversed-phase HPLC method for the analysis of Terbinafine in pharmaceutical dosage forms, Asian J. Chem, 20, 551 Rani, 2006, Reverse phase HPLC determination of Terbinafine hydrochloride in tablets, Asian J. Chem., 18, 3154 Kassem, 2013, High performance liquid chromatography method for the determination of Terbinafine hydrochloride in semi solids dosage form, Int. J. Pharm. Sci. Rev. Res., 21, 58 Domadiya, 2012, Method development and validation for assay of Terbinafine HCl in cream by RP-HPLC method, Inventi Impact: Pharm. Anal. Qual. Assur., 131 Ji, 1997, Determination of Terbinafine hydrochloride, Chlorhexidine and Triamcinolone acetonide acetate in compound ointment by RP-HPLC, Chin. J. Pharm. Anal., 17, 363 Raju, 2011, Simultaneous analysis of RP-HPLC method development and validation of Terbinafine and Bezafibrate drugs in pharmaceutical dosage form, Pharmacophore, 2, 232 Abdel, 2003, Chromatographic determination of Terbinafine in presence of its photodegradation products, Saudi Pharm. J., 11, 37 Cardoso, 1999, High-performance liquid chromatographic assay of Terbinafine hydrochloride in tablets and creams, J. Pharm. Biomed. Anal., 19, 809, 10.1016/S0731-7085(98)00119-8 Vamsi, 2014, Simple, sensitive and stability indicating high performance liquid chromatographic assay of Terbinafine hydrochloride in dosage forms, Am. J. PharmTech Res., 4, 899 Matysova, 2006, Separation and determination of Terbinafine and its 4 impurities of similar structure using simple RP-HPLC method, Talanta, 68, 713, 10.1016/j.talanta.2005.05.013 Ahmad, 2009, Stability-indicating high-performance thin layer chromatographic method for analysis of Terbinafine in pharmaceutical formulations, Acta Chromatogr., 21, 631, 10.1556/AChrom.21.2009.4.9 Suma, 2011, HPTLC method for determination of Terbinafine in the bulk drug and tablet dosage form, Int. J. ChemTech Res., 3, 742 Patel, 2012, A validated HPTLC method for the determination of Terbinafine hydrochloride in pharmaceutical dosage forms, Int. J. Pharm. Sci. Res., 3, 4492 Mikus, 2005, determination of Terbinafine in pharmaceuticals and dialyzates by capillary electrophoresi, Talanta, 65, 1031, 10.1016/j.talanta.2004.08.039 Felix, 2012, Quantification of Terbinafine in pharmaceutical tablets using capillary electrophoresis with contactless conductivity detection and batch injection analysis with amperometric detection, Talanta, 101, 220, 10.1016/j.talanta.2012.09.006 Cargo, 2001, Optimization of a separation of antifungals by capillary zone electrophoresis, J. Chromatogr., A 917, 337, 10.1016/S0021-9673(01)00664-1 Cardoso, 2000, Microbiological assay for Terbinafine hydrochloride in tablets and creams, Int. J. Pharm., 203, 109, 10.1016/S0378-5173(00)00439-7 Wang, 2008, Voltammetric determination of Terbinafine in biological fluid at glassy carbon electrode modified by cysteic acid/carbon nanotubes composite film, Bioelectrochemistry, 72, 107, 10.1016/j.bioelechem.2007.11.014 Haeuser, 1988, A new bioassay for Terbinafine, Eur. J. Clin. Microbiol. Infect. Dis., 7, 531, 10.1007/BF01962608 Kan, 1986, Bioassay for SF 86-327, a new antifungal agent, Antimicrob. Agents Chemother., 30, 628, 10.1128/AAC.30.4.628 Denoueel, 1995, Determination of Terbinafine and its desmethyl metabolite in human plasma by high-performance liquid chromatography, J. Chromatogr. B, 663, 353, 10.1016/0378-4347(94)00449-F Zehender, 1995, Simultaneous determination of Terbinafine (Lamisil) and five metabolites in human plasma and urine by high performance liquid chromatography using online solid-phase extraction, J. Chromatogr. B, 664, 347, 10.1016/0378-4347(94)00483-L Baramosuka, 2009, Development and validation of an HPLC method for the simultaneous analysis of 23 selected drugs belonging to different therapeutic groups in human urine samples, Anal. Sci., 25, 1307, 10.2116/analsci.25.1307 Schatz, 1989, Analytical methods for the determination of Terbinafine and its metabolites in human plasma, milk and urine, Arzneimittel-Forschung, 39, 527 Yeganeh, 2000, Determination of Terbinafine in tissues, Biomed. Chromatogr., 14, 261, 10.1002/1099-0801(200006)14:4<261::AID-BMC983>3.0.CO;2-X Dykes, 1990, Determination of Terbinafine in nail samples during systemic treatment for onychomycoses, Br. J. Dermatol., 123, 481, 10.1111/j.1365-2133.1990.tb01453.x Kuzner, 2001, Determination of terbinafine hydrochloride in cat hair by two chromatographic methods, Biomed. Chromatogr., 15, 497, 10.1002/bmc.108 UnalOzer, 2011, HPLC-UV method transfer for UPLC in bioanalytical analysis: determination of Terbinafine from human plasma, J. Fac. Pharm. Istanbul Univ., 41, 56 Baranowska, 2010, Rapid UHPLC method for simultaneous determination of Vancomycin, Terbinafine, Spironolactone, Furosemide and their metabolites: application to human plasma and urine, Anal. Sci., 26, 755, 10.2116/analsci.26.755 Dotsikas, 2007, An improved high-throughput liquid chromatographic/tandem mass spectrometric method for Terbinafine quantification in human plasma, using automated liquid-liquid extraction based on 96-well format plates, Biomed. Chromatogr., 21, 201, 10.1002/bmc.738 Brignol, 2000, Quantitative analysis of Terbinafine (Lamisil) in human and minipig plasma by liquid chromatography tandem-mass spectrometry, Rapid Commun. Mass Spectrom., 14, 141, 10.1002/(SICI)1097-0231(20000215)14:3<141::AID-RCM856>3.0.CO;2-I de Oliveira, 2001, Terbinafine quantification in human plasma by high-performance liquid chromatography coupled to electrospray tandem mass spectrometry: application to a bio-equivalence study, Ther. Drug Monit., 23, 709, 10.1097/00007691-200112000-00019 Majumdar, 2000, Determination of Terbinafine (Lamisil) in human hair by microbore liquid chromatography/tandem mass spectrometry, Rapid Commun. Mass Spectrom., 14, 1214, 10.1002/1097-0231(20000730)14:14<1214::AID-RCM12>3.0.CO;2-5 Grego, 2001, Fast separation of Terbinafine and eight of its main metabolites by capillary electrophoresis, J. Sep. Sci., 24, 265, 10.1002/1615-9314(20010401)24:4<265::AID-JSSC265>3.0.CO;2-9 AL-Ghannam, 2006, A simple spectrophotometric method for the determination of β-blockers in dosage forms, J. Pharm. Biomed. Anal., 40, 151, 10.1016/j.jpba.2001.12.001 Abdine, 2000, Spectrophotometric determination of Cisapride using some sulfonpthalein dyes, Alex. J. Pharm. Sci., 14, 75 Waheed, 1999, Single step method for estimating nano gram quantities of protein, Anal. Biochem., 275, 124, 10.1006/abio.1999.4301 Liu, 2002, Spectrophotometric determination of Vitamin B1 in a pharmaceutical formulation using triphenylmethane acid dyes, J. Pharm. Biomed. Anal., 30, 685, 10.1016/S0731-7085(02)00356-4 Abdel-Hay, 2004, Spectrophotometric determination of Bisacodyl and piribedyl, Anal. Lett., 37, 247, 10.1081/AL-120027790 Gouda, 2013, Development and validation of sensitive spectrophotometric method for determination of two antiepileptics in pharmaceutical formulations, Spectrochim. Acta Part-A, 105, 488, 10.1016/j.saa.2012.12.053 Abdel-Gawad, 1997, Spectrophotometric determination of pharmaceutical Piperazine derivatives through charge-transfer and ion-pair complexation reactions, J. Pharm. Biomed. Anal., 15, 1679, 10.1016/S0731-7085(96)01928-0 El-Yazbi, 2003, Spectrophotometric and titrimetric determination of Nizatidine in capsules, J. Pharm. Biomed. Anal., 31, 1027, 10.1016/S0731-7085(02)00699-4 Swamy, 2013, Selective and sensitive assay of Mebendazole in pharmaceuticals using BCG by spectrophotometry, Thail. J. Pharm. Sci., 37, 171 Swamy, 2013, Use of two sulfonphthalein dyes for the sensitive and selective extraction-free spectrophotometric assay of ASlbendazole in bulk drug and tablets, ISRN Anal. Chem., 10.1155/2013/734027 Raghu, 2012, Rapid and sensitive extraction-free spectrophotometric methods for the determination of Pheniramine maleate using three sulfonphthalein dyes, Proc. Natl. Acad. Sci., 82, 187 Vinay, 2012, Use of two sulfonphthalein dyes in the extraction-free spectrophotometric assay of Tramadol in dosage forms and spiked human urine based on ion-pair reaction, J. Drug Test. Anal., 4, 116, 10.1002/dta.247 Rajendraprasad, 2010, Sensitive and selective extraction-free spectrophotometric determination of Quetapinefumarate in pharmaceuticals using two sulfonphthalein dyes, J. Preclin. Clin. Res., 4, 24 Shama, 2002, Spectrophotometric determination of phenylephrine HCl and orphenadrine citrate in pure and in dosage forms, J. Pharm. Biomed. Anal., 30, 1385, 10.1016/S0731-7085(02)00437-5 Basavaiah, 2011, Utility of sulphothaline dyes for the extraction-free spectrophotometric determination of Famotidine in pharmaceutical formulations, Quim. Nova, 34, 735 Vinay, 2011, Sensitive and selective extraction-free spectrophotometric determination of Lamotrigine in pharmaceuticals using two sulfonphthalein dyes, Thail. J. Pharm. Sci., 35, 65 Sameer, 2009, Simple and sensitive spectrophotometric determination of Olanzapine in pharmaceutical formulations using two sulfonphthalein dyes, J. Food Drug Anal., 17, 434 A.H. Beckett, J.B. Stenlake, Practical pharmaceutical chemistry, 4th Ed., Athlone Press, UK 1968, pp. 304. Bakshi, 2002, Development of validated stability-indicating assay methods – critical review, J. Pharm. Biomed. Anal., 28, 1011, 10.1016/S0731-7085(02)00047-X Blessy, 2014, Development of forced degradation and stability-indicating studies of drugs – a review, J. Pharm. Anal., 4, 159, 10.1016/j.jpha.2013.09.003 ICH guideline, Q3A (R2): Draft Revised Guidance on Impurities in New Drug Substances, 2006, pp. 1–15. G.D. Christian, Analytical Chemistry, 6th Ed., Wiley India (P) Ltd., New Delhi, 2004, pp. 547 Novakova, 2006, Advantages of applications of UPLC in pharmaceutical analysis, Talanta, 68, 908, 10.1016/j.talanta.2005.06.035 Kuffmann, 1993, Pharmaceutical and biomedical applications of electroanalysis, Anal. Chim. Acta, 273, 32 Wang, 1988 Ion Gh. Tanase, Techniques and Methods of Electrometrical Analysis, Docendi Ars Publishing, Bucharest, 2000. Altria, 2001, 972 Morzunova, 2006, Capillary electrophoresis in pharmaceutical analysis, Pharm. Chem. J., 40, 158, 10.1007/s11094-006-0083-x