• Chilaka Ratnaraju
• Dr.Raviteja Bandla

Analytical method development and validation are ongoing, interconnected processes crucial to the operations of research and development, quality control, and quality assurance departments in the pharmaceutical industry. In line with these objectives, the present study focused on developing an efficient and straightforward HPLC method for the determination of Ivosidenib in its bulk form, which was subsequently applied to analyze marketed Ivosidenib formulations. Ivosidenib is a pharmaceutical compound that functions as a small molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), a mutation linked to various types of cancer.For the HPLC analysis, the mobile phase comprised Methanol and 0.1M Sodium Acetate Buffer in a 60:40 (v/v) ratio. The chromatographic separation was performed on a Zorbax Eclipse Plus C18 column (250 mm × 4.6 mm; 5 µm) under isocratic conditions. The Ivosidenib peak was well-resolved and detected at a wavelength of 246 nm using a UV detector.The method demonstrated linearity over a concentration range of 10–70 μg/mL for Ivosidenib. Validation was conducted in accordance with International Council for Harmonisation (ICH) guidelines, covering essential parameters such as system suitability, specificity, precision, accuracy, and robustness. The method's sensitivity was confirmed, with limits of detection (LOD) and quantification (LOQ) determined to be 0.039 µg/mL and 0.129 µg/mL, respectively, enabling the detection of even minimal concentrations of the drug.Furthermore, the method exhibited stability-indicating capabilities by effectively separating degradation products generated during forced degradation studies. Based on these results, the developed HPLC method was found suitable for the accurate separation and quantification of Ivosidenib in bulk drugs, pharmaceutical formulations, and stability testing, offering a robust and reliable tool for routine quality control and analytical applications.

A Comprehensive Stability-Indicating HPLC Approach for Quantification of Ivosidenib in bulk drug and Pharmaceutical formulations

"A Comprehensive Stability-Indicating HPLC Approach for Quantification of Ivosidenib in bulk drug and Pharmaceutical formulations", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 1, page no.c749-c762, January-2025, Available :http://www.jetir.org/papers/JETIR2501286.pdf

"A Comprehensive Stability-Indicating HPLC Approach for Quantification of Ivosidenib in bulk drug and Pharmaceutical formulations", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 1, page no. ppc749-c762, January-2025, Available at : http://www.jetir.org/papers/JETIR2501286.pdf