Abstract
A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of Terbinafine HCl (TRH) and linezolid (LNZ) in their pharmaceutical formulations. The proposed method is based on measuring the native fluorescence of the studied drugs in water at 336 nm after excitation at 275 nm for TRH and 375 nm after excitation at 254 nm for LNZ. The fluorescence–concentration plots were rectilinear over the range of 0.02–0.15 μg/mL for TRH and 0.5–5.0 μg/mL for LNZ. With lower detection limits of 3.0 and 110.0 ng/mL and a lower quantification limit of 9.0 and 320.0 ng/mL for TRH and LNZ, respectively. The method was successfully applied to the analysis of TRH in its commercial tablets, cream, gel and spray formulations and the results were in good agreement with those obtained with the official method. In addition the method was also applied to the analysis of LNZ in its capsule and I.V solution and the results were in good agreement with those obtained with the comparison method. The effect of sensitizers was studied. The method was extended to the determination of the studied drugs in spiked human plasma and the results were satisfactory.
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References
Budavari S (1996) The Merck Index. 12 th ed. Merck and Co., New Jersey, USA, p 1564
Sweetman SC (2011) Martindale: The Complete Drug Reference” 37th Ed. The Pharmaceutical Press, London, pp 594–595, 319-321
Block JH, Beale JM (2011) Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry 12th Ed. Lippincott Williams & Wilkins, Philadelphia, pp 200–323
The United States Pharmacopoeia XXXIV (2011) the National Formulary XXIX. The US Pharmacopoeia Convention: Rockville, Rockville, pp 4362–4367
The British Pharmacopoeia (2010), Her Magesty’s Stationary Office: London, Vol. II, pp 2050, 2051.
The European PharmacopoeiaVII (2011), Strsburg.; Vol. II, pp 3047,3048.
Suma BV, Kannan K, Madhavan V, Nayar CR (2011) HPTLC method for determination of Terbinafine in the bulk drug and tablet dosage form. Int J Chem Tech Res 3(2):742–748
Kurosaki H, Inaba Y (2011) Simple method for determination of antifungal agents in nails by thin film chromatography. Jpn. Kokai Tokkyo Koho JP 2011069673 A 20110407.
Ahmad S, Jain GK, Faiyazuddi M, Iqbal Z, Talegaonkar S, Sultana Y, Ahmad FJ (2009) Stability-indicating high-performance thin-layer chromatographic method for analysis of terbinafine in pharmaceutical formulations. Acta Chromatogr 21(4):631–639
Bisceglia KJ, Yu JT, Coelhan M, Bouwer EJ, Roberts AL (2010) Trace determination of pharmaceuticals and other wastewater-derived micropollutants by solid phase extraction and gas chromatography/mass spectrometry. J Chromatogr A 1217(4):558–564
Li D, Sun C, Li C, Li Y (2008) Determination of residual solvents in terbinafine hydrochloride by gas chromatography with capillary column. LihuaJianyan, Huaxue Fence 44(2):152–153
Liu H, Guo M, Xu D, Fan R (2011) Simultaneous determination of terbinafine hydrochloride and econazole nitrate in Teyi cream by HPLC. ZhongguoYaoshi 14(7):1002–1004
Min G, Sa-Jing L, Cui-hua L, Zhi-gin Z, Guo-zhu H (2009) Simultaneous determination of two ingredients in compound terbinafine cream by reversed-phase HPLC. Zhongguo Xinyao Zazhi 18(22):2167–2169, 2171
Shiru Y, Shaoyang G, Hongling Z, Ping Y, Wuyuan C (2008) Improved study on determination of content of terbinafine hydrochloride cream. Yaowu Fenxi Zazhi 28(4):656–657
Tagliari MP, Kuminek G, Borgmann SHM, Bertol C, Cardoso SG (2010) Terbinafine: optimization of a LC method for quantitative analysis in pharmaceutical formulations and its application for a tablet dissolution test. Quimica Nova 33(8):1790–1793
Gopal PNV, Hemakumar AV, Padma SVN (2008) Reversed-phase HPLC method for the analysis of terbinafine in pharmaceutical dosage forms. Asian J Chem 20(1):551–555
Rani BS, Reddy PV, Babu GS, Sankar GG, Rao JVLNS (2006) Reverse phase HPLC determination of terbinafine hydrochloride in tablets. Asian J Chem 18(4):3154–3156
Luo S, Chen H (2006) Determination of terbinafine hydrochloride content in Kemeishu liniments by HPLC. Zhongguo Yiyuan Yaoxue Zazhi 26(3):353–355
Baranowska I, Wilczek A, Baranowski J (2010) Rapid UHPLC method for simultaneous determination of vancomycin, terbinafine, spironolactone, furosemide and their metabolites: application to human plasma and urine. Anal Sci 26(7):755–759
Tan F, Peng Y, Li R, Zhang L, Gong P (2009) Determination of terbinafine hydrochloride in human plasma by HPLC. Yiyao Daobao 28(12):1543–1545
Baranowska I, Markowski P, Baranowski J (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(11):1307–1313
Gong Z (2008) Determination of terbinafine in human plasma by HPLC and its pharmacokinetics. Zhongguo Yiyao Gongye Zazhi 39(8):603–605
Elazazy MS, El-Mammli M, Shalaby A, Ayad MM (2008) Application of certain ion – pairing reagents for extractive spectrophotometric determination of flunarizine hydrochloride, ramipril, and terbinafine hydrochloride. Biosci Biotech Res Asia 5(1):107–114
Florea M, Monciu C (2008) Spectrophotometric determination of terbinafine through ion-pair complex formation with methyl orange. Farmacia 56(4):393–401
Yu W, Wang Q, Pan M (2005) Determination of UV-spectrophotometry method of terbinafine hydrochloride gel and studying of methodology. Dalian Yike Daxue Xuebao 27(6):463–465
Mikus P, Valaskova I, Havranek E (2005) Determination of terbinafine in pharmaceuticals and dialyzates by capillary electrophoresis. Talanta 65(4):1031–1037
Crego AL, Gomez J, Lavandera JL (2001) Fast separation of terbinafine and eight of its metabolites by capillary electrophoresis. J Sep Sci 24(4):265–270
Elsayed MMA, Vierl U, Cevc G (2009) Accurate Potentiometric Determination of Lipid Membrane-Water Partition Coefficients and Apparent Dissociation Constants of Ionizable Drugs: Electrostatic Corrections. Pharm Res 26(6):1332–1343
Elazazy MS, El-Mammli MY, Shalaby A, Ayad MM (2008) Conductometric determination of some important carboxylic acid derivatives and hydrochlorides in pharmaceutical formulations. Chemia Anal 53(5):725–736
Wang C, Mao Y, Wang D, Yang G, Qu Q, Hu X (2008) Voltammetric determination of terbinafine in biological fluid at glassy carbon electrode modified by cysteic acid/carbon nanotubes composite film. Bioelectrochem 72(1):107–115
Samy AI, Sayed SA, Haroon AA (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(1&2):139–143
Patel S (2012) Visible spectrophotometric method for estimation of linezolid in tablet and injection dosage form. Int J Pharma Res 4(1):67–69
Mathrusri AM, Satish KK, Sai Gangadhara RMVV (2012) New derivative spectrophotometric methods for the determination of Linezolid – an antibacterial drug. J Chem Pharm Res 4(1):714–718
Joshi RA, Pingale PL (2011) Development and validation of UV-spectrophotometric method for the linezolid in solid dosage form. Res J Pharm Tech 4(1):82–84
Abdel Kawy M, Weshahy SA, Shokry DS (2012) Validated stability indicating assay of linezolid by spectrophotometric and high performance liquid chromatographic methods. Aust J Basic Appl Sci 6(3):767–778
Mei H, Bai N, Liang B, Wang R (2012) Determination of linezolid concentration in human plasma by HPLC. Zhongguo Linchuang Yaolixue Zazhi 28(4):295–297
Mohapatra S, Annapurna MM, Kumar RBVV, Anwar M, Warsi MH, Akhter S (2011) Validated stability indicating RP-HPLC method for the estimation of linezolid in a pharmaceutical dosage form. J Liq Chromatogr 34(18):2185–2195
Patel SA, Patel PU, Patel NJ, Patel MM, Bangoriya UV (2007) High performance thin layer chromatographic method for estimation of linezolid in tablets. Indian J Pharm Sci 69(4):571–574
Michalska K, Pajchel G, Tyski S (2008) Determination of linezolid and its achiral impurities using sweeping preconcentration by micellar capillary electrophoresis. J Pharm Biomed Anal 48(2):321–330
Merli D, Pretali L, Fasani E, Albini A, Profumo A (2011) Analytical Determination and Electrochemical Characterization of the Oxazolidinone Antibiotic Linezolid. Electroanal 23(10):2364–2372
Skoog DA, West DM, Holler FJ, Crouch SR (2004) Fundamentals of analytical chemistry, 8th edn. Saunders College Publishing, Philadelphia, PA, pp 1003–1006
42- ICH Harmonized tripartite guidelines, validation of analytical procedures: text and methodology, Q2(R1), 2005: http://www.ich.org/LOB/media/ MEDIA417.pdf (accessed 15 February 2008).
Miller JC, Miller JN (2005) Statistics and chemometrics for analytical chemistry, 5th ed. Pearson Education, Harlow, UK, pp 39–73, 107–49, 25
Welshman IR, Stalker DJ, Wajsczuk CP (1998) Assessment of absolute bioavailability and evaluation of the effect of food on oral bioavailability of linezolid. Anti-Infect Drugs Chemother 16(1):54
Gee T, Ellis R, Marshall G, Andrews J, Ashby J, Wise R (2001) Pharmacokinetics and tissue penetration of linezolid following multiple oral doses; Antimicrob. Agents. Chemother 45:1843–5
Slatter JG, Stalker DJ, Feenstra KL, Welshman IR, Bruss JB, Sams JP, Johnson MG, Sanders P, Hauer MJ, Fagerness PE et al (2001) Pharmacokinetics, metabolism and excretion of linezolid following an oral dose of 14C linezolid to healthy human subjects. Drug Metab Dispos 29:1136–45
Hendershot PE, Antal EJ, Welshman IR, Batts DH, Hopkins NK (2001) Linezolid: pharmacokinetic and pharmacodynamic evaluation of co-administration with pseudoephedrine HCl, phenylpropanolamine HCl, and dextromethorphan HBr. J Clin Pharmacol 41:563–72
48- Stalker DJ, Wajszczuk CP, Batts DH. (1997) Linezolid safety, tolerance and pharmacokinetics following oral dosing twice daily for 14.5 days. In: Abstracts of the Thirty-Seventh Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Canada. Abstract A-115, p 23. American Society for Microbiology, Washington, DC, USA.
Sisson TL, Jungbluth GL, Hopkins NK (1999) A pharmacokinetic evaluation of concomitant administration of linezolid and aztreonam. J Clin Pharmacol 39:1277–82
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Belal, F., Sharaf El-Din, M.K., Eid, M.I. et al. Spectrofluorimetric Determination of Terbinafine Hydrochloride and Linezolid in their Dosage Forms and Human Plasma. J Fluoresc 23, 1077–1087 (2013). https://doi.org/10.1007/s10895-013-1237-3
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DOI: https://doi.org/10.1007/s10895-013-1237-3