Author(s)

Vasudev Pottabathini¹, Vijayacharan Gugulothu¹, Muralidharan Kaliyaperumal², Satyanarayana Battu^1*

¹Department of Chemistry, University College of Science, Osmania University, Hyderabad, India.
²GVK Bio Sciences Pvt. Ltd., Hyderabad, India.

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.

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

Pottabathini, V. , Gugulothu, V. , Kaliyaperumal, M. and Battu, S. (2016) Identification, Isolation and Characterization of Unknown Acid Degradation Product of Nevirapine. American Journal of Analytical Chemistry, 7, 663-678. doi: 10.4236/ajac.2016.79061.