International Journal of Drug Delivery Technology
Volume 14, Issue 2

Stability Indicating Force Degradation Study of Nintedanib in Bulk and Pharmaceutical Dosage Form

Sachin Kadam1*, Rohit Bhalerao1, Sonali Pawar1, Harshal Tare2

1Vishal Institute of Pharmaceutical Education and Research, Ale, Affiliated to Savitribai Phule Pune University, Pune, Maharashtra, India.

2Dr. Harshal Tare (OPC) Pvt. Ltd., Jalgaon, Maharashtra, India. 

Received: 28th March, 2024; Revised: 10th April, 2024; Accepted: 10th May, 2024; Available Online: 25th June, 2024 

ABSTRACT

Assay of the nintedanib drug substance can be determined using a newly designed and verified reverse-phase high-performance liquid chromatography (RP-HPLC) method, even when degradation products from forced degradation experiments are present. By using gradient elution, the mobile phase was a mixture of 70% acetonitrile and 30% water by volume. Acid, base, peroxide, thermal, and photolytic degradation were among the stress conditions that the product was subjected to. During the thermal and photolytic breakdown processes, no extra contaminants were detected. Using validation criteria such as specificity, linearity, limit of quantitation (LoQ), accuracy, precision, robustness, and ruggedness, the developed technique was validated in accordance with International Council for Harmonization (ICH) recommendations. At a concentration of 12.4 ng/mL, the LoQ value was attained. The results showed good linearity (r2 > 1.00) across doses ranging from 2 to 10 µg/mL. Verification of recovery was done by adding concentrated solutions of 5, 10, and 15 µg/mL. So, newly developed RP-HPLC technology can separate Nintedanib from its main degradation products, and it can also estimate the drug substance’s concentration.

Keywords: Nintedanib, Chromatography, Degradation, Stability.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.41

How to cite this article: Kadam S, Bhalerao R, Pawar S, Tare H. Stability Indicating Force Degradation Study of Nintedanib in Bulk and Pharmaceutical Dosage Form. International Journal of Drug Delivery Technology. 2024;14(2):879-885.

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