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Floridia, M., Bucciardini, R., Ricciardulli, D., Fragola, V., Pirillo, M.F., Weimer, L.E., Tomino, C., Giannini, G., Galluzzo, C.M., Andreotti, M. and Cargnel, A. (1999) A Randomized, Double-Blind Trial on the Use of a Triple Combination Including Nevirapine, a Nonnucleoside Reverse Transcriptase HIV Inhibitor, in Antiretroviral-Naive Patients with Advanced Disease. JAIDS Journal of Acquired Immune Deficiency Syndromes, 20, 11-19.
http://dx.doi.org/10.1097/00042560-199901010-00002

has been cited by the following article:

• TITLE: Identification, Isolation and Characterization of Unknown Acid Degradation Product of Nevirapine

  AUTHORS: Vasudev Pottabathini, Vijayacharan Gugulothu, Muralidharan Kaliyaperumal, Satyanarayana Battu

  KEYWORDS: Nevirapine, Method Development, Validation, Forced Degradation, Unknown Impurity, Isolation, Characterization, NMR, HRMS

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.7 No.9, September 28, 2016

  ABSTRACT: A Novel stability indicating RP-UPLC chromatographic method was developed for analysis of Nevirapine in pharmaceutical formulations. The developed RP-UPLC method is superior in technology to conventional RP-HPLC with respect to speed, resolution, solvent consumption and cost of analysis. Nevirapine was subjected to the stress conditions like acid, base, thermal, oxidative and photolytic degradation. Nevirapine was found to degrade significantly in acid and thermal degradation. In acid degradation relative retention time with 0.42 is found as unknown impurity. New impurity was identified, isolated using mass based auto purification system and characterized by 1H NMR (1D and 2D) and HRMS experiments. Isolated impurity was showing molecular weight of 244.10, molecular formula C12H12N4O2 and its name as 2-(3-Amino-4-methylpyridin-2-ylamino)nicotinic acid. The calibration graph was linear and the method showed less deviation in accuracy results. The test solution was found to be stable for 20 days when stored in the refrigerator between 2°C to 8°C. The developed RP-UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines. The intra-day and inter-day variation was less than 1%. The method was reproducible and selective for the estimation of Nevirapine. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating method.