Open AccessDevelopment and validation of stability indicating HPTLC method for estimation of pirfenidone and characterization of degradation product by using mass spectroscopy
Author(s) -
Ritesh P. Bhole,
Supriya Jagtap,
Chandrakant Bonde,
Yogesh Zambare
Publication year - 2020
Publication title -
ķaraġandy universitetìnìn̦ habaršysy. himiâ seriâsy
Language(s) - English
Resource type - Journals
eISSN - 2663-4872
pISSN - 2518-718X
DOI - 10.31489/2020ch3/51-60
Subject(s) - chromatography , pirfenidone , degradation (telecommunications) , chemistry , forced degradation , densitometry , mass spectrometry , silica gel , calibration curve , detection limit , idiopathic pulmonary fibrosis , computer science , medicine , telecommunications , lung
Pirfenidone is used as a novel antifibrotic agent approved for mild-to-moderate idiopathic pulmonary fibrosis. An extensive literature search revealed that, method validation by high-performance thin-layer chromatography (HPTLC) and structural determination by tandem mass spectrometry (MS/MS) method was not reported till date. Precoated silica gels plates were used as a stationary phase. Methanol: ethyl acetate: toluene (1:2:7 v/v) was delivered best separation at 315 nm (Rf 0.49±0.03) by densitometry analysis. Degradation analysis was performed as per ICH guidelines Q2 (R1). Isolation of degradation product was done by the HPTLC method and characterized by using MS/MS method. All the validation parameters were found within the range. Moreover, its possible degradation pathway was also proposed. The Proposed developed and validated HPTLC method was found to be more sensitive, simple, precise, accurate, cost-effective and robust. This method could be applied for the analysis of bulk drug and tablet formulation, degradation study. This degradation pathway of the drug will further help to identify the degradation products of Pirfenidone which may be used for the impurity profiling of the drug.