Abstract

THE NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR RELATED SUBSTANCES OF NINTEDANIB ESYLATE BY RP-HPLC METHOD

*Yogendra B. Parmar, Dharmesh Shah, Yashraj A. Majmudar, Ketul C. Kaka, Arpan S. Patel, Pankaj D. Kankad and Uday G. Sartanpara

Abstract

An accurate, sensitive and rapid gradient reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for related substances of Nintedanib Esylate. HPLC analysis was performed on YMC Triart, C18 (250 x 4.6) mm, 3μm. Column temperature maintained at 35°C conditions. Chromatographic separation was achieved with mobile phase gradient program at flow rate of 1.0mL/min. The injection volume was 10μl. The UV detection wavelength was 245nm. The method suitability was checked and validated according to the ICH guidelines Q2 (R1) for specificity, linearity, accuracy, precision, limit of quantification, limit of detection. Limit of detection of each impurity was found to be less than 0.031% w/w indicating that the developed method is highly sensitive. The calibration curve of each impurity was found to be linear within the concentration range of about 0.10μg/ml to 2.0μg /ml. The regression data for calibration curve shows good linear relationship. Correl coefficient (r2) of each impurity was found to be greater than 0.998. The Recovery was found to be accurate for each impurity within the spike concentration range of about 0.10μg/ml to 1.5μg /ml. The Recovery of each impurity was found to be between 80% to 120%. The experiment results are given in detail in this research article.

Keywords: RP-HPLC, Method validation, Method Development, Nintedanib Esylate, Related substances.