Abstract

Dr. Santhosh Illendula*, Jetamoni Mahesh, Kurumeti Divya, Mothe Praneeth, Vusala Tejaswi, Varipally Sai Sindhu, Vootkuri Nihathi, Dr. Suthakaran Raj

ABSTRACT

Ensartinib is a potent, orally active, next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor used in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). Development of a simple, rapid, accurate, precise, and robust analytical method is important for the quantitative estimation of ensartinib in pharmaceutical formulations and biological samples. The present study focuses on the development and validation of an analytical method for the estimation of ensartinib using a suitable chromatographic technique. Method development involves optimization of chromatographic parameters such as stationary phase, mobile phase composition, flow rate, injection volume, detection wavelength, and run time to obtain satisfactory separation and peak characteristics. The developed method is subsequently validated according to ICH guidelines with respect to system suitability, specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, and solution stability. The method is expected to provide good linearity over the selected concentration range with acceptable accuracy and precision. The optimized chromatographic conditions should produce a sharp and symmetrical ensartinib peak with an appropriate retention time and adequate resolution. The validated method can be applied for the routine quality control analysis of ensartinib in bulk drug and pharmaceutical dosage forms. Thus, the developed method provides a reliable, reproducible, and economical approach for the estimation of ensartinib and may be useful for pharmaceutical quality-control studies.