Authors : M P. Shinde, Aishwarya Patil, A. P. Bendale, S. P. Narkhede, A G. Jadhav
DOI : 10.18231/2394-2797.2018.0023
Volume : 5
Issue : 3
Year : 0
Page No : 144-146
Tenofovir alafenamide is a nucleic acid analogue that is used for treatment of HIV infection and Hepatitis B. As compared with the other prodrug of tenofovir, tenofovir alafenamide is having less side effects, it is Steady in plasma and then quickly changed over into tenofovir once inside cells. The main aim and objective of present study was to perform the stability indicating studies as defined under ICH Guideline Q1A R2) by using UV spectrophotometer. According to ICH guidelines, of temperature, time, photo degradation, acid/base are the factors which are responsible for formation degradation product of a drug. UV-Vis spectroscopy method was intiated to study and compute the amount of drug in the presence of degradation products. The method was developed by using water as diluents and ? max was 260nm. Linearity was established for in the range of 2-10 ?g/mL with regression coefficient of 0.9912. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation degradation conditions. The limits of detection (LOD) and quantification (LOQ) were calculated and found to be 1.43 ?g/mL and 4.33?g/mL, respectively. The method was found to be simple, economic and less time consuming as compared to other analytical techniques.
Keywords: Stability indicating assay method, Tenofovir alafenamide fumarate.