Development and Validation of RP-HPLC Method for the Estimation of Nintedanib Esylate in Bulk and Its Formulation

Abstract

A simple, precise, reliable, rapid and reproducible reversed-phase high performance liquid
chromatographic method (RP-HPLC) method has was developed and validated for the
estimation of Nintedanib Esylate. Chromatography was carried out with analytical
technology. HPLC system consisted of UV-3000-M detector on C18 (4.6×250 mm, 5 μ)
column with a mobile phase composed of methanol:water (80:20 v/v) at a flow rate of
1 ml/min. The pH of the mobile phase was adjusted by 0.05% ortho phosphoric acid (pH-3).
Detection was carried out using a UV detector at 287 nm. Parameters such as linearity,
precision, accuracy, ruggedness, robustness, LOD and LOQ were studied as per the ICH Q2
(R1) guidelines. The retention time was found to be 4.67 min. The linearity range for
Nintedanib esylate was 10–60 μg/ml. The correlation coefficient was found to be 0.999.
Developed method was found to be accurate, precise, selective and rapid for estimation of
Nintedanib esylate in pharmaceutical dosage form. The proposed method can be useful in
quality control of bulk manufacturing and pharmaceutical dosage form.
Keywords: ICH guidelines, method validation, Nintedanib esylate, RP-HPLC