Stability-indicating UHPLC method for determination of nevirapine in its bulk form and tablets: identification of impurities and degradation kinetic study

Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor, is a drug widely used in the treatment of Acquired Immunodeficiency Syndrome (AIDS). The evaluation of NVP stability is of fundamental importance in order to guarantee drug product efficacy, safety and quality. In this study, NVP active pharmaceutical ingredient (API) and tablets were subjected to a detailed study of forced degradation, employing several degrading agents (acid, alkaline, water, metal ions, humidity, heat, light and oxidation agents). In order to determine NVP and the degradation products formed, a stability-indicating UHPLC method using fused core column was developed and validated. The separation was carried out using a Poroshell 120 C-18 column (100 x 2.1 mm i.d.; 2.7 mu m particle size) and the mobile phase was composed of acetonitrile and water in a gradient elution, at a flow rate of 0.2 ml/min. Chemical structures and mechanisms for the formation of three degradation products were proposed by means of LC/MS-MS. Also, NVP degradation kinetic was studied and its order of degradation evaluated. NVP was degraded in acidic and oxidative conditions and the degradation profile for NVP tablets and API were similar. The stability indicating method proved to be selective for NVP and its degradation products. Calibration curve was linear in the range of 8-48 mu g/ml and the method showed to be precise, accurate and robust for both NVP API and tablets, with detection and quantification limits of 0.092 mu g/ml and 0.174 mu g/ml, respectively. (C) 2016 Elsevier B.V. All rights reserved.