RP-HPLC-PDAAnalyses of Tapentadol: Application of Experimental Design

References

• Physicians’ Desk Reference, 64th edition, PDR Network, LLC, Montvale, NJ, (2009), pp. 2643–2648.
   Google Scholar
• Schedules of controlled substances: placement of tapentadol into schedule II. Final Rule Federal Register, (2009). 74(97): 23790–23793.
   Google Scholar
• Tzschentke, T.M., Christoph, T., Kögel, B., Schiene, K., Hennies, H. H., Englberger, W., et al., (2007). (–) - (1R, 2R)-3-(3Dimethylamino-1-ethyl-2-methylpropyl)-phenol Hydrochloride (Tapentadol HCl): a Novel ì-Opioid Receptor Agonist/Norepinephrine Reuptake Inhibitor with Broad Spectrum Analgesic Properties. J. Pharmacol. Exp. Ther., 323: 265–276. doi: 10.1124/jpet.107.126052
   PubMed Web of Science ®Google Scholar
• Bourland, J.A., Collins, A.A., Chester, S.A., Ramachandran, S., Backer, R.C., (2010). Determination of tapentadol (Nucynta®) and n-desmethyltapentadol in authentic urine specimens by ultra-performance liquid chromatography–tandem mass spectrometry. J. Anal. Toxicol., 34: 450–457. doi: 10.1093/jat/34.8.450
   PubMed Web of Science ®Google Scholar
• Coulter, C., Taruc, M., Tuyay, J., Moore C., (2010). Determination of tapentadol and its metabolite n-desmethyltapentadol in urine and oral fluid using liquid chromatography with tandem mass spectral detection. J. Anal. Toxicol., 34: 458–463. doi: 10.1093/jat/34.8.458
   PubMed Web of Science ®Google Scholar
• Hillewaerta, V., Puseckerb, K., Sipsa, L., Verhaeghea, T., Vriesa, R., Langhansb,M., et al., (2015). Determination of tapentadol and tapentadol-O-glucuronide in human serum samples by UPLC–MS/MS. J. Chrom. B., 981–982: 40–47 doi: 10.1016/j.jchromb.2014.12.013
   PubMed Web of Science ®Google Scholar
• Yi, J., Xue, J., Nan-nan, Z., Ping-wei, X., Bo, Y., Hai-yan, X., (2012). LC-MS/MS method for determination of tapentadol in rats. J. She. Pharm. Uni., 29: 143–146.
   Google Scholar
• Dousa, M., Lehnert, P., Adamusova, H., Bosakova, Z., (2013). Fundamental study of enantio- selective HPLC separation of tapentadol enantiomers using cellulose based chiral stationary phase in normal phase mode. J. Phar. Bio. Ana., 74: 111–116. doi: 10.1016/j.jpba.2012.10.017
   PubMed Web of Science ®Google Scholar
• Marathe, G.M., Patil, P.O., Patil, D.A., Patil, G.B., Bari S.B., (2013). Stability indicating RP-HPLC method for the determination of tapentadol in bulk and in pharmaceutical dosage form. Int. J. Che. Tech. Res., 5: 34–41.
   Google Scholar
• Gandhi, J., Shah, N.J., Lumbhani, A.N., (2012). Simple, rapid and cost effective method for routine analysis of tapentadol hydrochloride: a novel analgesic drug in bulk and pharmaceutical dosage form by RP–HPLC. Pharm. Sci. Mon., 3: 2440–2453.
   Google Scholar
• Rizwana, I., Prakash, K.V., Mohan, G.K., (2012). RP-HPLC method for determination of tapentadol in bulk and its pharmaceutical formulation. J. Glob. Trend. Pharm. Sci., 3: 755–762.
   Google Scholar
• Muzib, Y.I., Reddy, J.R., Chowdary, K.P.R., Swathi, E., (2013). Development and validation of RP-HPLC method for estimation of tapentadol hydrochloride in bulk and tablet dosage forms. Int. J. Chem. Ana. Sci., 4: 67–72. doi: 10.1016/j.ijcas.2013.07.001
   Google Scholar
• Kayesh, R., Hasan, S., Sultan, Z., (2013). A novel RP-HPLC method for quantification of tapentadol HCl in pharmaceutical formulations. Der Pharma Chem. 5: 94–100.
   Google Scholar
• Jain, D., Basniwal, P.K., (2013). ICH guideline practice: application of validated RP-HPLC- DAD method for determination of tapentadol hydrochloride in dosage form. J. Ana. Sci. Tech., 4: 1–7. doi: 10.1186/2093-3371-4-1
   Google Scholar
• Goud, E.S.K., Reddy, V.K., (2012). RP-HPLC determination of related substances of tapentadol in bulk and pharmaceutical dosage form; Int. J. Pharm. Bio. Sci., 2: 1–9.
   Google Scholar
• Lakshminarayana, M. V., Krishnaiah, A., Suneetha G., (2015). Development and validation of HPLC method for estimation of tapentadol and its process-related impurities. Der. Pharm. Lett. 7: 238–257.
   Google Scholar
• Gowrisankar, D., Rao, N.M., (2014). Development and validation of stability indicating RP- HPLC and UV-Spectroscopy methods for quantitative determination of tapentadol in pharma- ceutical dosage forms. J. Glob. Tre. Pharm. Sci., 5: 1466–1474.
   Google Scholar
• Sherikar, O.D., Mehta, P.J., (2012). Development and validation of RP-HPLC, UV-spectro-metric and spectrophotometric method for estimation of tapentadol hydrochloride in bulk and in laboratory sample of tablet dosage form. J. Chem. Pharm. Res., 4: 4134–4140.
   Google Scholar
• Dasu, Ch. D., Kumar, G.E., Kala, E.S., Mani, R.N.S., Lavanya, N.S.L., Rao, A.K., et al., (2012). Devolpment of new spectrophotometric methods for the quantitative analysis of tapentadol in pharmaceutical dosage forms. Cur. Pharm. Res., 3: 718–726.
   Google Scholar
• Krishnamoorthy, G., Gayathri, N., Ismail, A.M., Senthamarai, R., Banu, S.S., (2014). Determination of Tapentadol Hydrochloride in Bulk and Its Solid Dosage Form by UV- Spectro- photometry. Int. J. Pharm. Sci. Rev. Res., 25: 139–141.
   Google Scholar
• Kumar, Y.K., Prakash, K.V., Swetha, M., (2014). A New Facile and Sensitive Method for the Estimation of Tapentadol. Int. J. Pharm. Sci. Drug Res., 6: 82–84
   Google Scholar
• Rizwana, I., Prakash, K.V., Mohan, G. K., Samreen, J., Fatima, S., (2014). Validated colori- metric methods for the determination of tapentadol in bulk and in its tablet dosage form. Int. J. Cur. Tre. Pharm. Res., 2: 310–314.
   Google Scholar
• ICH Validation of Analytical Procedures: Text and Methodology, Q2 (R1), (2005). International Conference of Harmonization of Technical Requirements for Registration Pharmaceuticals for Human Use. IFPMA, Geneva, pp. 1–13.
   Google Scholar