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

2016 ◽  
Vol 126 ◽  
pp. 103-108 ◽  
Author(s):  
Naialy Fernandes Araújo Reis ◽  
Jéssica Camille de Assis ◽  
Sílvia Ligório Fialho ◽  
Gerson Antônio Pianetti ◽  
Christian Fernandes
2020 ◽  
Vol 3 (4) ◽  
pp. 94-101
Author(s):  
Payal J. Parmar ◽  
Vandana B. Patel ◽  
Dimal A. Shah

2020 ◽  
Vol 10 (2) ◽  
pp. 76-85
Author(s):  
Jitesha Patel ◽  
Parin Chokshi ◽  
Rajashree Mashru

A novel stability indicating RP- HPLC method was developed for the estimation of Apremilast in bulk and marketed formulation. Separation was achieved by using Shimadzu HPLC Analytical Technologies Limited C18 (250 mm x 4.6 mm, 5µm) as stationary phase. The optimized mobile phase consist of potassium dihydrogen ortho phosphate (pH-3.2): acetonitrile in ratio of 40:60 %v/v with flow rate of 1mL/min by using methanol as diluent. Retention time of Apremilast was found to be 5.4 min which was estimated at wavelength 360nm. Linearity of Apremilast was observed in the concentration range of 50-400µg/mL with r² value of 0.9999. Assay of Apremilast tablet was found to be 99.14-100.75%. Stability indicating nature of RP- HPLC method was estimated by conducting degradation kinetic study. The forced degradation of Apremilast bulk indicate that degradation in acidic, alkali, oxidative and photolysis condition were found to be 21%, 6.5%, 25.7% and 3.9% respectively. The kinetic study of apremilast in alkali degradation followed first order kinetic study. The result indicate that the developed RP-HPLC method is suitable for estimation of Apremilast in presence of degradant product. The above method was validated as per ICH guideline. Keywords: Apremilast, RP-HPLC, Validation, Forced Degradation Study, Alkali Degradation Kinetic study


2014 ◽  
Vol 77 (5-6) ◽  
pp. 523-524
Author(s):  
Mohamed R. Elghobashy ◽  
Lories I. Bebawy ◽  
Samah S. Abbas ◽  
Rafeek F. Shokry

Sign in / Sign up

Export Citation Format

Share Document