Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NINTEDANIB ESYLATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Shubham S. Jadhav*, Rishikesh S. Bachhav, Vaishali Y. Jadhav

ABSTRACT

Nintedanib is a tiny molecule which exhibits natural antagonist activity against tyrosine kinase receptor, inhibits collagen formation and is also used to treat the idiopathic pulmonary fibrosis. This method reports the development and validation of stability indicating RP-HPLC method for Nintedanib Esylate and its impurities. Nintedanib Esylate was subjected to force degradation under different conditions recommended by the International Conference on Harmonization to detect the degradation products. Chromatographic separation of Nintedanib Esylate was achieved using a gradient program at a flow rate of 1.0 ml/min on a Supelco Ascentis Baker bond C18 (150mm x
4.6 ID, Particle size: 5 micron) maintained at 30°C. The mobile phase consists of water pH 3.0 with Methanol: Water (90:10). UV detection was carried out at wavelength 390 nm. The developed RP-HPLC method was validated as per ICH guidelines with respect to accuracy, specificity, precision, linearity, ruggedness, robustness, LOD and LOQ.

Keywords: Nintedanib Esylate, Stability Study, Validation.