Skip to main content
SpringerLink
Log in

HPLC Method for the Dosage of Paclitaxel in Copaiba Oil: Development, Validation, Application to the Determination of the Solubility and Partition Coefficients

  • Original
  • Published:
Chromatographia Aims and scope Submit manuscript

Abstract

A highly sensitive, simple, rapid, innovative and economic method has been developed and validated for the quantification of paclitaxel in a complex plant matrix, copaiba oil, by HPLC method. Chromatographic separation was performed by Uptisphere Strategy C-18 column and the detection was performed at 228 nm. No interfering peaks from highly complex matrices were observed during the paclitaxel elution. Standard curves of paclitaxel containing 10 mg of copaiba resin oil were linear over the concentration range from 200 to 1700 ng mL−1 with a determination coefficient of 0.999 and lower regression residues with a homoscedastic dispersion. The lower quantification and detection limits were 33.8 and 10.1 ng mL−1, respectively. The accuracy and precision determinations were less or equal to 0.60 and 2.03 %, respectively. The method developed was successfully applied to the evaluation of paclitaxel in copaiba resin and essential oils by solubility and partition coefficient studies. Paclitaxel showed a lipophilic characteristic (log P > 1) and a higher solubility in copaiba oils. In conclusion, the method showed sensitivity, linearity, precision, accuracy, necessary specificity and robustness for a reliable separation, identification and quantification of paclitaxel in complex plant matrix. This new analytical method can be, therefore, also applied to quantify paclitaxel in drug delivery systems in which copaiba resin or essential oils are associated, such as lipid and polymer systems.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Fang WS, Liang XT (2005) Recent progress in structure activity relationship and mechanistic studies of taxol analogues. Mini Rev Med Chem 5:1–12

    Article  CAS  Google Scholar 

  2. Wani MC, Taylor HL, Wall ME, Coggon P, McPhail AT (1971) Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc 93:2325–2327

    Article  CAS  Google Scholar 

  3. Frense D (2007) Taxanes: perspectives for biotechnological production. Appl Microbiol Biotechnol 73:1233–1240

    Article  CAS  Google Scholar 

  4. Gueritte-Voegelein F, Guenard D, Dubois J, Wahl A, Potier P (1994) Chemical and biological studies on taxol (paclitaxel) and taxotere (docetaxel), new antineoplastic agents. J Pharm Belg 49:193–205

    CAS  Google Scholar 

  5. Kajani AA, Moghim S, Mofid MR (2012) Optimization of the basal medium for improving production and secretion of taxanes from suspension cell culture of Taxus baccata L. Daru 20:54

    Article  CAS  Google Scholar 

  6. Kim SC, Yu J, Lee JW, Park ES, Chi SC (2005) Sensitive HPLC method for quantitation of paclitaxel (Genexol) in biological samples with application to preclinical pharmacokinetics and biodistribution. J Pharm Biomed Anal 39:170–176

    Article  CAS  Google Scholar 

  7. Huizing MT, Misser VH, Pieters RC, ten Bokkel Huinink WW, Veenhof CH, Vermorken JB, Pinedo HM, Beijnen JH (1995) Taxanes: a new class of antitumor agents. Cancer Invest 13:381–404

    Article  CAS  Google Scholar 

  8. Rowinsky EK, Cazenave LA, Donehower RC (1990) Taxol: a novel investigational antimicrotubule agent. J Natl Cancer Inst 82:1247–1259

    Article  CAS  Google Scholar 

  9. Rowinsky EK, Onetto N, Canetta RM, Arbuck SG (1992) Taxol: the first of the taxanes, an important new class of antitumor agents. Semin Oncol 19:646–662

    CAS  Google Scholar 

  10. Singla AK, Garg A, Aggarwal D (2002) Paclitaxel and its formulations. Int J Pharm 235:179–192

    Article  CAS  Google Scholar 

  11. Guo P, Ma J, Li S, Gallo JM (2003) Determination of paclitaxel in mouse plasma and brain tissue by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 798:79–86

    Article  CAS  Google Scholar 

  12. Alencar EN, Xavier-Junior FH, Morais ARV, Dantas TRF, Dantas-Santos N, Verissimo LM, Rehder VLG, Chaves GM, Oliveira AG, Egito EST (2015) Chemical characterization and antimicrobial activity evaluation of natural oil nanostructured emulsions. J Nanosci Nanotechnol 15:880–888

    Article  CAS  Google Scholar 

  13. Sousa JP, Brancalion AP, Souza AB, Turatti IC, Ambrosio SR, Furtado NA, Lopes NP, Bastos JK (2011) Validation of a gas chromatographic method to quantify sesquiterpenes in copaiba oils. J Pharm Biomed Anal 54:653–659

    Article  CAS  Google Scholar 

  14. Xavier-Junior FH, Maciuk A, Morais ARV, Alencar EN, Rehder VLG, Egito EST, Vauthier C Development of gas-chromatography method for the analysis of copaiba oil (submitted)

  15. Legault J, Pichette A (2007) Potentiating effect of beta-caryophyllene on anticancer activity of alpha-humulene, isocaryophyllene and paclitaxel. J Pharm Pharmacol 59:1643–1647

    Article  CAS  Google Scholar 

  16. Gomes NM, Rezende CM, Fontes SP, Matheus ME, Fernandes PD (2007) Antinociceptive activity of amazonian copaiba oils. J Ethnopharmacol 109:486–492

    Article  Google Scholar 

  17. Leandro LM, Vargas FS, Barbosa PC, Neves JK, Silva JA, Veiga-Junior VF (2012) Chemistry and biological activities of terpenoids from copaiba (Copaifera spp.) oleoresins. Molecules 17:3866–3889

    Article  CAS  Google Scholar 

  18. Santos AO, Ueda-Nakamura T, Dias-Filho BP, Veiga-Junior VF, Pinto AC, Nakamura CV (2008) Antimicrobial activity of Brazilian copaiba oils obtained from different species of the Copaifera genus. Mem Inst Oswaldo Cruz 103:277–281

    Article  Google Scholar 

  19. Song D, Au JL (1995) Isocratic high-performance liquid chromatographic assay of taxol in biological fluids and tissues using automated column switching. J Chromatogr B Biomed Appl 663:337–344

    Article  CAS  Google Scholar 

  20. Supko JG, Nair RV, Seiden MV, Lu H (1999) Adaptation of solid phase extraction to an automated column switching method for online sample cleanup as the basis of a facile and sensitive high-performance liquid chromatographic assay for paclitaxel in human plasma. J Pharm Biomed Anal 21:1025–1036

    Article  CAS  Google Scholar 

  21. Ahmad J, Kohli K, Mir SR, Amin S (2013) Development and validation of RP-HPLC method for analysis of novel self-emulsifying paclitaxel formulation. Res Rev J Pharm Anal 2:17–27

    CAS  Google Scholar 

  22. Choudhury H, Gorain B, Karmakar S, Pal TK (2014) Development and validation of RP-HPLC method: scope of application in the determination of oil solubility of paclitaxel. J Chromatogr Sci 52:68–74

    Article  CAS  Google Scholar 

  23. Wang LZ, Ho PC, Lee HS, Vaddi HK, Chan YW, Yung CS (2003) Quantitation of paclitaxel in micro-sample rat plasma by a sensitive reversed-phase HPLC assay. J Pharm Biomed Anal 31:283–289

    Article  CAS  Google Scholar 

  24. International Conference on Harmonization (ICH) (2005) Q2 (R1): validation of analytical procedures: text and methodology, November 2005. http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-methodology.html. Accessed 22 Feb 2016

  25. Mohammadi A, Esmaeili F, Dinarvand R, Atyabi F, Walker RB (2009) Development and validation of a stability-indicating method for the quantitation of paclitaxel in pharmaceutical dosage forms. J Chromatogr Sci 47:599–604

    Article  CAS  Google Scholar 

  26. Badea I, Ciutaru D, Lazar L, Nicolescu D, Tudose A (2004) Rapid HPLC method for the determination of paclitaxel in pharmaceutical forms without separation. J Pharm Biomed Anal 34:501–507

    Article  CAS  Google Scholar 

  27. Lee SH, Yoo SD, Lee KH (1999) Rapid and sensitive determination of paclitaxel in mouse plasma by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 724:357–363

    Article  CAS  Google Scholar 

  28. Konno T, Watanabe J, Ishihara K (2003) Enhanced solubility of paclitaxel using water-soluble and biocompatible 2-methacryloyloxyethyl phosphorylcholine polymers. J Biomed Mater Res A 65:209–214

    Article  Google Scholar 

  29. Zhao D, Zhao X, Zu Y, Li J, Zhang Y, Jiang R, Zhang Z (2010) Preparation, characterization, and in vitro targeted delivery of folate-decorated paclitaxel-loaded bovine serum albumin nanoparticles. Int J Nanomed 5:669–677

    CAS  Google Scholar 

  30. Silva KGH, Xavier-Junior FH, Farias IEG, Caldas-Neto JA, Silva AKAS, Nakashima-Junior T, Araujo IB, Oliveria AG, Medeiros AC, Egito EST (2006) A new insight about pharmaceutical dosage forms for benzathine penicillin G. J Basic Appl Pharm Sci 27:21–26

    Google Scholar 

  31. Balbach S, Korn C (2004) Pharmaceutical evaluation of early development candidates “the 100 mg-approach”. Int J Pharm 275:1–12

    Article  CAS  Google Scholar 

  32. Lee H, Soo PL, Liu J, Butler M, Allen C (2006) In: Amiji MM (ed) Nanotechnology for cancer therapy. CRC Press, New York

    Google Scholar 

  33. Surapaneni MS, Das SK, Das NG (2012) Designing paclitaxel drug delivery systems aimed at improved patient outcomes: current status and challenges. ISRN Pharmacol 2012:623139

    Article  Google Scholar 

  34. Zabaleta V, Ponchel G, Salman H, Agueros M, Vauthier C, Irache JM (2012) Oral administration of paclitaxel with pegylated poly(anhydride) nanoparticles: permeability and pharmacokinetic study. Eur J Pharm Biopharm 81:514–523

    Article  CAS  Google Scholar 

Download references

Acknowledgments

Financial supports were obtained from "Coordenação de Aperfeiçoamento de Pessoal de Nível Superior- CAPES" (grant to Xavier-Junior FH) through the CAPESCOFECUB project #721/11.

Author information

Authors and Affiliations

  1. Laboratório de Sistemas Dispersos (LaSiD), Departamento de Farmácia, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Av. Gal. Gustavo Cordeiro de Farias, S/N, Petrópolis, Natal, RN, 59010-180, Brazil

    Francisco Humberto Xavier Junior, Andreza Rochelle do Vale Morais, Everton do Nascimento Alencar & Eryvaldo Sócrates Tabosa do Egito

  2. Univ Paris-Sud, CNRS, Institut Galien Paris Sud, Université Paris Saclay, 92296, Chatenay-Malabry Cedex, France

    Francisco Humberto Xavier Junior, Claire Gueutin, Andreza Rochelle do Vale Morais & Christine Vauthier

Authors
  1. Francisco Humberto Xavier Junior
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Claire Gueutin
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Andreza Rochelle do Vale Morais
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Everton do Nascimento Alencar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Eryvaldo Sócrates Tabosa do Egito
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Christine Vauthier
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Christine Vauthier.

Ethics declarations

Conflict of interest

The authors declares that they have no conflict of interest.

Ethical Statement

This article does not contain any studies with human participants or animals performed by any of the authors.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Xavier Junior, F.H., Gueutin, C., do Vale Morais, A.R. et al. HPLC Method for the Dosage of Paclitaxel in Copaiba Oil: Development, Validation, Application to the Determination of the Solubility and Partition Coefficients. Chromatographia 79, 405–412 (2016). https://doi.org/10.1007/s10337-016-3058-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10337-016-3058-4

Keywords

Search

Navigation