• Badikela. Rama krishna
• Ratnakar Cherukupally
• Shaik Harun Rasheed

For the detection of enasidenib, an innovative reversed phase high performance liquid chromatography approach that is simple, fast, accurate, and selective was created and verified. The Symmetry ODS C18 (4.6 x 150 mm, 5 µm) column was used to make the separation. At a wavelength of 272 nm, the mobile phase utilized included ethanol: water adjusted with an orthophosphoric acid solution in a 50:50% v/v ratio in isocratic mode. For the determination of Enasidenib in bulk and its injected sample volume, the mobile-phase flow rate and the technique that was developed and validated were 1 ml/min and 10 μl, respectively. Enasidenib was shown to have a retention time of 2.8 ±0.2 minutes. Over a concentration range of 20 to 100µg/ml of Enasidenib, a solid linear interaction (r=0.999) was found. Enasidenib's limit of quantification (LOQ) and limit of detection (LOD) were determined to be 6.35 µg/ml and 2.6 µg/ml, respectively. The degree of recovery was found to be between 98 and 102%. The precision study's relative standard deviation was less than 2%. Enasidenib in bulk and marketed pharmaceutical dosage forms may be estimated using the devised approach since it is quick, easy, exact, specific, and accurate. The drug product was subjected to hydrolysis (acid and base hydrolysis), H2O2, thermal degradation, and light degradation during force degradation. Within the specified conditions, the percentage of deterioration for both Enasidenib was determined to be between 10 and 20%. The suggested techniques, which may be applied to the simultaneous estimate of Enasidenib in tablet dose form, were simple, precise, and cost-effective.

Enasidenib, RP-HPLC, stability indicating study and ICH Q2 (R1) Guidelines.

"DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF A NOVEL ROBUST ANALYTICAL METHOD FOR ANTI-NEOPLASTIC AGENT ESTIMATION USING LIQUID CHROMATOGRAPHY", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 1, page no.e187-e203, January-2025, Available :http://www.jetir.org/papers/JETIR2501424.pdf

"DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF A NOVEL ROBUST ANALYTICAL METHOD FOR ANTI-NEOPLASTIC AGENT ESTIMATION USING LIQUID CHROMATOGRAPHY", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 1, page no. ppe187-e203, January-2025, Available at : http://www.jetir.org/papers/JETIR2501424.pdf