JPC - Journal of Planar Chromatography - Modern TLC
Volume/Issue:
Volume 17: Issue 4
Stability-indicating high-performance thin-layer chromatographic determination of zidovudine as the bulk drug and in pharmaceutical dosage forms
Authors:
Neeraj Kaul Bharati Vidyapeeth Deemed University, Poona College of Pharmacy Department of Quality Assurance Techniques Erandwane Pune-411038 Maharashtra State India

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Himani Agrawal Bharati Vidyapeeth Deemed University, Poona College of Pharmacy Department of Quality Assurance Techniques Erandwane Pune-411038 Maharashtra State India

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Anant Paradkar Bharati Vidyapeeth Deemed University, Poona College of Pharmacy Department of Quality Assurance Techniques Erandwane Pune-411038 Maharashtra State India

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Kakasaheb Mahadik Bharati Vidyapeeth Deemed University, Poona College of Pharmacy Department of Quality Assurance Techniques Erandwane Pune-411038 Maharashtra State India

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Pages:
264–274
Online Publication Date:
08 Mar 2007
Publication Date:
01 Aug 2004
Article Category:
Research Article
DOI:
https://doi.org/10.1556/jpc.17.2004.4.5
Restricted access

A sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatographic method has been established and validated for analysis of zidovudine both as the bulk drug and in formulations. The method employs aluminum-backed silica gel 60F 254 HPTLC plates with toluene-carbon tetrachloride-methanol-acetone, 3.5 + 3.5 + 2.0 + 1.0 ( v/v ), as mobile phase. This system was found to give compact spots ( RF 0.41 ± 0.02) for zidovudine.Densitometric analysis of zidovudine was performed in absorbance mode at λ = 270 nm. Response was linearly dependent on amount of zidovudine in the range 100–6000 ng per spot with a significantly high correlation coefficient ( r2 = 0.998 ± 0.53). Linear regression analysis data for the calibration plots showed there was a good linear relationship with r2 = 0.998 ± 0.0003 in the working concentration range 100 to 1000 ng per spot. The mean values of the slope and intercept were 0.063 ± 0.004 and 39.61 ± 1.09, respectively.The method was validated for precision, robustness, and recovery. The limits of detection and quantitation were, respectively, 20 and 40 ng per spot. Statistical analysis proved the method was repeatable and selective for estimation of the drug.Zidovudine was subjected to acid and alkaline hydrolysis, to oxidation, to dry and wet heat treatment, and to photodegradation; it was found to undergo degradation under all these conditions except dry heat treatment. The degradation products were well separated from the pure drug with significantly different RF values. Because the method can effectively separate the drug from its degradation products, it can be employed for stability-indicating analysis.The proposed HPTLC method was used to investigate the kinetics of acid degradation. An Arrhenius plot was constructed and the activation energy was calculated.

  • J.E.F. Reynold (Ed.) Martindale, The Extra Pharmacopoeia, 30th edn, Pharmaceutical Press, London, 1993.

    '', in Martindale, The Extra Pharmacopoeia , (1993 ) -.

  • P.A. Furman, J.A. Fyte, M.H. Clair, K. Weinhold, J.L. Rideout, G.A. Freeman, S.N. Lehrman, D.P. Bolognesi, S. Broder, H. Mitsuya , and D.W. Barry , Proc. Natl Acad. Sci. USA 83 (1986) 8333.

    Barry D.W. , '' (1986 ) 83 Proc. Natl Acad. Sci. USA : 8333 -.

  • G.X. McLeod and S.M. Hammer , Ann. Intern. Med. 117 (1992) 487–501.

    Hammer S.M. , '' (1992 ) 117 Ann. Intern. Med. : 487 -501 .

  • K. Peter, J.P. Lalezari , and J.G. Gambertoglio , J. Pharm. Biomed. Anal. 14 (1996) 491–499.

    Gambertoglio J.G. , '' (1996 ) 14 J. Pharm. Biomed. Anal. : 491 -499 .

  • X. Tan and F.D. Boudinot , J. Chromatogr. B 740 (2000) 281–287.

    Boudinot F.D. , '' (2000 ) 740 J. Chromatogr. B : 281 -287 .

  • T. Nadal, J. Ortuno , and J.A. Pascual , J. Chromatogr. A 721 (1996) 127–137.

    Pascual J.A. , '' (1996 ) 721 J. Chromatogr. A : 127 -137 .

  • K.B. Kenny, S.A. Wring, R.M. Corr, G.N. Wells , and J.A. Dunn , J. Pharm. Biomed. Anal. 22 (2000) 967–983.

    Dunn J.A. , '' (2000 ) 22 J. Pharm. Biomed. Anal. : 967 -983 .

  • A.S. Pereira, K.B. Kenny, M.S. Cohen , and J.E. Hall , J. Chromatogr. B 742 (2000) 173–183.

    Hall J.E. , '' (2000 ) 742 J. Chromatogr. B : 173 -183 .

  • V.A. Simon, M.D. Thiam , and L.C. Lipford , J. Chromatogr. A 913 (2001) 447–453.

    Lipford L.C. , '' (2001 ) 913 J. Chromatogr. A : 447 -453 .

  • E. Marchei, L. Valvo , and R. Pacifici , J. Pharm. Biomed. Anal. 29 (2002) 1081–1088.

    Pacifici R. , '' (2002 ) 29 J. Pharm. Biomed. Anal. : 1081 -1088 .

  • B. Fan and J.T. Steward , J. Pharm. Biomed. Anal. 28 (2002) 903–908.

    Steward J.T. , '' (2002 ) 28 J. Pharm. Biomed. Anal. : 903 -908 .

  • G. Aymard, M. Legrand, N. Trichereau , and B. Diquet , J. Chromatogr. B 744 (2000) 227–240.

    Diquet B. , '' (2000 ) 744 J. Chromatogr. B : 227 -240 .

  • B. Uslu and S.A. Ozkan , Anal. Chim. Acta 466 (2002) 175–185.

    Ozkan S.A. , '' (2002 ) 466 Anal. Chim. Acta : 175 -185 .

  • ICH, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonization, Geneva, October 1993.

  • K. Ferenczi-Fodor, Z. Végh, A. Nagy-Turák, B. Renger , and M. Zeller , J. AOAC Int. 84 (2001) 1265–1276.

    Zeller M. , '' (2001 ) 84 J. AOAC Int. : 1265 -1276 .

  • K. Ferenczi-Fodor and Z. Végh , in: Sz. Nyiredy (Ed.) Planar chromatography — A retrospective view for the third millennium, Springer, Budapest, 2001, pp. 336–352.

    Végh Z. , '', in Planar chromatography — A retrospective view for the third millennium , (2001 ) -.

  • Thin Layer Chromatography, monograph 2.2.27, European Pharmacopoeia, Council of Europe, 4.5, 2002, p. 3638.

  • ICH, Q2A Validation of Analytical Procedure: Methodology, International Conference on Harmonization, Geneva, October, 1994.

  • ICH, Q2B Validation of Analytical Procedure: Methodology, International Conference on Harmonization, Geneva, March, 1996.

  • ICH Guidance on Analytical Method Validation, International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September, 2002.

  • P.D. Sethi , High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations, CBS, 1996.

  • E.R. Garrett and R.F. Carper , J. Am. Pharm. Assoc. Sci. 44 (1955) 515–521.

    Carper R.F. , '' (1955 ) 44 J. Am. Pharm. Assoc. Sci. : 515 -521 .
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Cover JPC - Journal of Planar Chromatography - Modern TLC
JPC - Journal of Planar Chromatography - Modern TLC
Print ISSN:
0933-4173
Online ISSN:
1789-0993

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Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation		 1988
Volumes
per Year		 1
Issues
per Year		 6
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

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