RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NINTEDANIB IN BULK AND PHARMACEUTICAL DOSAGE FORM

M. Sindhuja*, A. Rajamani and A. Yasodha

ABSTRACT

A simple, selective, rapid and precise reversed-phase high-performance liquid chromatographic method for analysis of Nintedanib in bulk and tablet dosage form has been developed and validated. Chromatography was performed on a Waters C18, 5μm particle size, 25cmx4.6mm i.d. with Phosphate buffer (pH adjusted with orthophosphoric acid): Acetonitrile in the ratio of 45:55 v/v as mobile phase at a flow rate of 1.0 mL min−1. UV detection was performed at 243 nm. Total run time was 9.0 min. Nintedanib were eluted with retention time of 4.398 minutes. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with USP and ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0-50μgmL−1 for Nintedanib. Limit of detection were 0.003mg mL−1 and limit of quantification were 0.009mg mL−1 for Nintedanib. The high recovery and low coefficients of variation confirm the suitability of the method for analysis of the drug in tablet dosage form. The validated method was successfully used for quantitative analysis of bulk and Marketed Pharmaceutical dosage forms.

Keywords: Nintedanib, RP-HPLC, Method Development, Validation, Accuracy.