Asian Journal of Research in Chemistry

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development, Validation and Stress Degradation Studies of Emtricitabine and Tenofovir Disoproxil Fumerate by High Performance Liquid Chromatography


Affiliations
1 Department of Chemistry, GITAM Institute of Technology, GITAM University, Visakhapatnam, A P, India
2 Research Scholar, Department of Chemistry, Acharya Nagarjuna University, Guntur A P, India
3 Research Scholar, Department of Chemistry, GITAM University, Visakhapatnam, A P, India
     

   Subscribe/Renew Journal


A simple, selective, rapid, precise and accurate reverse phase high pressure liquid chromatographic method has been developed for simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumerate in pharmaceutical Tablet dosage form. The mobile phase consisted of 65:35 % (v/v) of Methanol and 0.1M of potassium di hydrogen ortho phosphate and pH adjusted to 3.2 with ortho phosphoric acid.The method developed is operated on isocratic mode.The flow rate is 1.0 ml/min. Chromatographic determination of Emtricitabine and Tenofovir disoproxil fumerate was performed on Phenomenex C18 column (150 X 4.6 mm Id, ODS-2, 5μm). The wavelength of detection is 260 nm. The injection volume is 20μL. The retention time of Emtricitabine is 1.92 ± 0.01 minutes while the retention time of Tenofovir disoproxil fumerate is 3.17 ± 0.01minures.The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, solution stability, ruggedness, and robustness. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress conditions on Emtricitabine and Tenofovir disoproxil fumerate was studied. Results indicated that Emtricitabine and Tenofovir disoproxil fumerate is stable under the experimental conditions. The proposed method has been successfully used for the estimation in tablet dosage forms.

Keywords

Emtricitabine, Tenofovir Disoproxil Fumerate, Anti-retrovirals, Assay, HPLC
Subscription Login to verify subscription
User
Notifications
Font Size


  • www.pubchem/Emtricitabine

  • www.pubchem/Tenofovir disoproxil fumerate

  • www.wikepedia/Emtricitabine

  • www.Wikepedia/Tenofovir disoproxil fumerate

  • HPTLC method Development, Validation for Simultaneous Determination of Efavirenz, Emtricitabine and Tenofovir in combined tablet formulation and Forced Degradation Studies. Nikalje Anna Pratima, Maniyar Ajhar, Obaid Shaikh, AJPTR, volume-3,February 2013.

  • Joshi M, Nikalje A P, Shahed M, Dehghan M. HPTLC method for the simultaneous estimation of emtricitabine and tenofovir in tablet dosage form. Indian J Pharm Sci 2009;71:95-7.

  • Choudhari VP, Ingale S, Gite SR, Tajane DD, Modak VG, Ambekar A. Spectrophotometric simultaneous determination of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form by ratio derivative, first order derivative and absorbance corrected methods and its application to dissolution study. Pharm Methods 2011;2:47-52.

  • Choudhari VP, Ingale KD, Barhate A, Kale AN, Bobade CD, Kuchekar BS. Development and validation of Simultaneous and Isoabsorptive UV -Spectrophotometric methods for Tenofovir and Emtricitabine in Pharmaceutical Formulations. J Pharm Res. 2010;9:11–13.

  • Ghorpade SA, Sali MS, Kategaonkar AH, Patel DM, Choudhari VP, Kuchekar BS. Simultaneous determination of emtricitabine and tenofovir by area under curve and dual wavelength spectrophotometric method. J Chil Chem. Soc. 2010;54:331–33.

  • Jullien V, Treéluyer J, Pons G, Rey E. Determination of tenofovir in human plasma by high-performance liquid chromatography with spectrofluorimetric detection. J Chromatogr B.2003;785: 377–81.

  • Notari S, Bocedi A, Ippolito G, Narciso P, Pucillo LP, Tossini G, et al. Simultaneous determination of 16 anti-HIV drugs in human plasma by high-performance liquid chromatography. J Chromatogr B.2006;831:258–66.

  • Rezk NL, Crutchley RD, Kashuba AD. Simultaneous quantification of emtricitabine and tenofovir in human plasma using high-performance liquid chromatography after solid phase extraction. J Chromatogr B. 2005;822:201–08.

  • Gomes NA, Vaidya VV, Pudage A, Joshi SS, Parekh SA. Liquid chromatography–tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study. J Pharm Biomed Anal. 2008;48:918–26.

  • Bezy V, Morin P, Couerbe P, Leleu G, Agrofoglio L. Simultaneous analysis of several antiretroviral nucleosides in ratplasma by high-performance liquid chromatography with UV using acetic acid/hydroxylamine buffer Test of this new volatile medium-pH for HPLC-ESI-MS/MS. J Chromatogr B. 2005; 82:132–43.

  • ICH-Q2B Validation of Analytical Procedures: Methodology International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.


Abstract Views: 946

PDF Views: 2




  • Development, Validation and Stress Degradation Studies of Emtricitabine and Tenofovir Disoproxil Fumerate by High Performance Liquid Chromatography

Abstract Views: 946  |  PDF Views: 2

Authors

Battula Sreenivasa Rao
Department of Chemistry, GITAM Institute of Technology, GITAM University, Visakhapatnam, A P, India
Siva Nagaraju
Research Scholar, Department of Chemistry, Acharya Nagarjuna University, Guntur A P, India
B.V. Kiran
Research Scholar, Department of Chemistry, GITAM University, Visakhapatnam, A P, India

Abstract


A simple, selective, rapid, precise and accurate reverse phase high pressure liquid chromatographic method has been developed for simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumerate in pharmaceutical Tablet dosage form. The mobile phase consisted of 65:35 % (v/v) of Methanol and 0.1M of potassium di hydrogen ortho phosphate and pH adjusted to 3.2 with ortho phosphoric acid.The method developed is operated on isocratic mode.The flow rate is 1.0 ml/min. Chromatographic determination of Emtricitabine and Tenofovir disoproxil fumerate was performed on Phenomenex C18 column (150 X 4.6 mm Id, ODS-2, 5μm). The wavelength of detection is 260 nm. The injection volume is 20μL. The retention time of Emtricitabine is 1.92 ± 0.01 minutes while the retention time of Tenofovir disoproxil fumerate is 3.17 ± 0.01minures.The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, solution stability, ruggedness, and robustness. The influence of Acid, Alkaline, Oxidative Stress, Photolytic stress conditions on Emtricitabine and Tenofovir disoproxil fumerate was studied. Results indicated that Emtricitabine and Tenofovir disoproxil fumerate is stable under the experimental conditions. The proposed method has been successfully used for the estimation in tablet dosage forms.

Keywords


Emtricitabine, Tenofovir Disoproxil Fumerate, Anti-retrovirals, Assay, HPLC

References