Stability indicating HPLCc method for impurities estimation of nevirapine in extended release tablet dose

• Authors: Ch. Venkata Reddiaha , P. Rama Devib , K. Mukkantic , P. Srinivasu
• Languages of publication: EN

Abstracts

EN

A novel, sensitive and selective Reverse phase High performance liquid chromatographic method was developed for quantitative determination of Nevirapine in its Extended Tablet dosage forms. The synthetic non-nucleoside reverse transcriptase inhibitor analogues (NNRTI) Nevirapine form one of the Extended dosage in HIV. It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). The method is applicable to the quantification of related compounds of Nevirapine forming one of the fixed Extended dosage. Chromatographic separation of Nevirapine from the possible impurities and the degradation products was achieved on an Supelcosil LC-ABZ 150 x 4.6 mm, 5.0μm column; Ammonium Orthophosphate pH 5.0 as mobile phase A and Acetonitrile taken as mobile phase B in the ratio (85 : 15). The flow rate was 1.0 mL/min, and the detection was done at 220 nm. The above developed HPLC method was further subjected to hydrolytic, oxidative, photolytic and thermal stress conditions. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, and ruggedness

Keywords

EN

Nevirapine XR; force degradation studies; validation

• Publisher: Wydawnictwo Uniwersytetu Marii Curie-Skłodowskiej
• Journal: Annales Universitatis Mariae Curie-Skłodowska, sectio AA – Chemia
• Year: 2012
• Volume: 67
• Issue: 1-2
• Pages: 163-173

Dates

published

1 - 12 - 2012

online

25 - 01 - 2014

Contributors

author

Ch. Venkata Reddiaha

author

P. Rama Devib

author

K. Mukkantic

author

P. Srinivasu

References

• [1] Martindale: The Complete Drug Reference, (S.C. Sweetman, Ed.), 32nd ed., The Pharmaceutical Press, London, pp. 622, 623, 630, (1996).
• [2] United States Pharmacopeia, United States Pharmacopeia Convention, Rockville, MD, pp. 2795-2798, (2008).
• [3] European Pharmacopoeia, Stationary Office London, pp. 2495-2496, (2008).
• [4] N. Kaul, H. Agarwal, A.R. Paradkar, and K.R. Mahadik, Talanta, 62, 843, (2004), [5] K. Namita, K. Sateesh, and P. Ramesh, Anal. Chimica. Acta, 570, 41, (2006).
• [6] W. Samee, P. Srilamai, S. Ongart, R. Suwannaratana, Ch. Sornchaithawatwong, and S. Vorarat, J. Thai. Pharm. Health. Sci., 2, 39, (2007).
• [7] D.A. Kumar, M.V. Naveen Babu, J.V.L.N. Seshagiri Rao, and V. Jajathirtha Rao, RASAYAN. J. Chem., 1, 94, (2010).
• [8] M. Vogel, N. Betram, J.C. Wasmuth, J. Emmelkamp, J.K. Rockstroh, and C. Reichel, J. Chromatogr. Sci., 48, 91, (2010).
• [9] O.M.S. Minzi and E. Ngaimisi, J. Chem. Pharm. Res., 2, 431, (2010).
• [10] C.H.V Kumar, D.A. Kumar, and J.V.L.N. Seshagiri Rao, E-J.Chem., 7, 821, (2010).
• [11] C. Ghosh, S. Gaur, A. Singh, C.P. Shinde, and B.S. Chakraborty, J. Bioequiv. Availab., 3, 20, .(2011)
• [12] A. Aguiar Castro, R. Queiroz Aucelio, N. Adrian Rey, E. Monsores Miguel, and P. Augusto Mardini Farias, Com. Chem. High T. SCR., 14, 22, (2011).
• [13] T.V. Sreevidya and B. Narayana, Eclet. Quim., 35, 93, (2010).
• [14] United States Pharmacopeia, United States Pharmacopeia Convention, Rockville, MD, pp. 2498-2499, (2008).
• [15] United States Pharmacopeia, United States Pharmacopoeia Convention, Rockville, MD, pp. 3539-3542, (2008).
• [16] ICH Guidance on Analytical Method Validation, [in:] Proc. Int.Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September (2002)
• [17] R.L. Murphy, J. Montaner, Drug Evaluations Anti-infectives: Nevirapine: A review of its development, pharmacological profile and potential for clinical use, Expert Opin. Investig. Drugs, 5, 1183, (1996), http://dx.doi.org/10.1517/13543784.5.9.1183.[Crossref]
• [18] R.L. Murphy and J. Montaner. Nevirapine: a review of its development, pharmaceutical profile and potential for clinical use.Exp. Opin. Invest. Drugs 5, 1183, (1996).[Crossref]
• [19] The year’s top ten medical advances. Health Mag.January/February: 132, (2000).
• [20] R.M. Dinallo, W.C. Davidson, and G.E. Hansen. The characterization of synthetic by-products by B/E linked scanning and high-resolution thermospray mass spectrometry. Bio. Mass Spectrom., 20, 268, (1991). [PubMed]
• [21] K.A. Cohen, J. Hopkins, R.H. Ingraham, C. Pargellis, J.C. Wu, D.E.H. Palladino, P. Kinkade, T.C. Warren, S. Rogers, J. Adams, P.R. Farina, and P.M. Grob. Characterization of the binding site for nevirapine (BI-RG-587), a nonnucleoside inhibitor of human immunodeficiency virus type-1 reverse transcriptase. J. Bio. Chem. 266, 14670, (1991).
• [22] D.E.H. Palladino, J.L. Hopkins, R.H. Ingraham, T.C.Warren, S.R. Kapadia, G.J. van Moffaert, P.M. Grob, J.M. Stevenson, and K.A. Cohen. High-performance liquid chromatography and photoaffinity cross-linking to explore the binding environment of nevirapine to reverse transcriptase of human immunodeficiency virus type-1. J. Chromatogr. A, 676, 99, (1994).
• [23] ICH Harmonized Tripartite Guideline Q3A. Impurities in new drug substances, step 4, adopted in March 1995.
• [24] ICH Harmonized Tripartite Guideline Q2A. Text on validation of analytical procedures, step 4, adopted on October 27, 1994.
• [25] ICH Harmonized Tripartite Guideline Q2B. Validation of analytical methods: definition and terminology, step 4, adopted on November 6, 1996.
• [26] M.V. Gorenstein, J.B. Li, J. Van Antwerp, and D. Chapman.Detecting coeluted impurities by spectral comparison, LC-GC, 12, 768, (1994).

Identifiers

DOI

10.2478/v10063-012-0008-3