Identification and Characterization of Degradation Products by Using MS-MS Studies for Developed and Validated Stability Indicating HPTLC Method for Estimation of Nintedanib Esylate in Pharmaceutical Dosage Form

Abstract

Nintedanib esylate was widely reported as tyrosine kinase inhibitor. As there is
no HPTLC method was reported for nintedanib drug the objective of this work is to develop
simple, precise, fast, accurate and validated HPTLC method for estimation of this drug.
Also, to carry out forced degradation study of nintedanib esylate and identification of
isolated stressed sample of nintedanib esylate by MS-MS studies. HPTLC is the widely
recognized for its reliability and for its sensitivity. A validated method was developed using
camag HPTLC. Stability studies were carried out as per standard guidelines. The degradant
peaks were then subjected for its characterisation and identification by using MS-MS
studies. The method is found to be simple precise and accurate. The Rf value is found to be
0.53. Linearity shows 0.9979. The stability studies shows that the sample is degraded
under acidic, basic and oxidative stress condition. MS-MS studies revels that there is
formation of 10 degradation products which was characterized and identified. Proposed
HPTLC method developed and validated which is successfully applicable for
pharmaceutical dosage form containing this drug. The characterization and identification
of degradation products may be use further for impurity profiling of nintedanib esylate