Development of a UV-spectrophotometric method for study of degradation profile of tenofovir alafenamide
Journal Title: International Journal of Pharmaceutical Chemistry and Analysis - Year 2018, Vol 5, Issue 3
Abstract
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 acidbase are the factors which are responsible for formation degradation product of a drug UVVis 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 210 gmL with regression coefficient of 09912 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 143 gmL and 433gmL respectively The method was found to be simple economic and less time consuming as compared to other analytical techniquesKeywords Stability indicating assay method Tenofovir alafenamide fumarate
Authors and Affiliations
M P. Shinde, Aishwarya Patil, A. P. Bendale, S. P. Narkhede, A G. Jadhav
Keywords
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- EP ID EP481453
- DOI 10.18231/2394-2797.2018.0023
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