• SUBBA RAO YARLAGADDA Research Scholars, Department of Chemistry, Acharya Nagarjuna University, Guntur-522510, AP, India
  • SUBBA RAO MANNAM Department of Chemistry, Acharya Nagarjuna University, Guntur-522510, AP, India
  • BABY PADMINI JAMPANI Department of Chemistry, Sri Vasavi Institute of Engineering and Technology, Nandamuru, Pedana, AP, India.



Sotorasib, RP-HPLC, Development, Validation, Stability


Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredient of Sotorasib.

Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Sotorasib. The chromatographic strategy utilized symmetry C18 column of dimensions 150x4.6 mm, 3.5 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% orthophosphoric acid (70:30). A flow rate of 1 ml/min and a detector wavelength of 221 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.

Results: LOD and LOQ for the active ingredient were established with respect to test concentration. The calibration chart plotted was linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drug.


Download data is not yet available.


Beumer JH, Chu E, Salamone SJ. Body-surface area-based chemotherapy dosing: appropriate in the 21st century? J Clin Oncol 2012;30:3896–7.

Hunter RJ, Navo MA, Thaker PH, Bodurka DC, Wolf JK, Smith JA. Dosing chemotherapy in obese patients: actual versus assigned body surface area (BSA). Cancer Treat Rev 2009;35:69–78.

Safar AM, Spencer H, Su X, Coffey M, Cooney CA, Ratnasinghe LD, et al. Methylation profiling of archived non-small cell lung cancer: a promising prognostic system. Clin Cancer Res 2005;11:4400–5.

Reck M, Rodriguez Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 2016;375:1823–33.

Nagy A, Pongor LS, Szabo A, Santarpia M, Gyorffy B. KRAS driven expression signature has prognostic power superior to mutation status in non-small cell lung cancer. Int J Cancer 2017;140:930–7.

Guo W, Wu S, Liu J, Fang B. Identification of a small molecule with synthetic lethality for K-ras and protein kinase C iota. Cancer Res 2008;68:7403–8.

Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, et al. The clinical KRAS (G12C) inhibitor AMG 510 drives anti-tumor immunity. Nature 2019;575:217–23.

Das S, Jayaratne R, Barrett KE. The role of ion transporters in the pathophysiology of infectious diarrhea. Cell Mol Gastroenterol Hepatol 2018;6:33–45.

Kumaraveloo, Sakthiaseelan K, Lunner Kolstrup, Christina. Agriculture and musculoskeletal disorders in low-and middle-income countries. J Agromedicine 2018;23:227–48.

Balaban CD, Yates BJ. What is nausea? A historical analysis of changing views. Auton Neurosci 2017;202:5–17.

Zielinski MR, Systrom DM, Rose NR. Fatigue, sleep, and autoimmune and related disorders. Front Immunol 2019;10:1827.

Davis JM, Alderson NL, Welsh RS. Serotonin and central nervous system fatigue: nutritional considerations. Am J Clin Nutr 2000;72:573S–8S.

Wang HJ, Gao B, Zakhari S, Nagy LE. Inflammation in alcoholic liver disease. Annu Rev Nutr 2012;32:343–68.

Goldsobel AB, Chipps BE. Cough in the pediatric population. J Pediatr 2010;156:352–8.

Wennerberg K, Rossman KL, Der CJ. The ras superfamily at a glance. J Cell Sci 2005;118:843–6.

Rocks O, Peyker A, Bastiaens PI. Spatio-temporal segregation of ras signals one ship, three anchors, many harbors. Curr Opin Cell Biol 2006;18:351–7.

Tammela, Tuomas, Sage, Julien. investigating tumor heterogeneity in mouse models. Annual Rev Cancer Biol 2020;4:99–119.

Bond Smith G, Banga N, Hammond TM, Imber CJ. Pancreatic adenocarcinoma. Br Med J 2012;344:e2476.

Juul JS, Hornung N, Andersen B, Laurberg S, Olesen F, Vedsted P. The value of using the faecal immunochemical test in general practice on patients presenting with non-alarm symptoms of colorectal cancer. Br J Cancer 2018;119:471–9.

Guinney J, Dienstmann R. The consensus molecular subtypes of colorectal cancer. Nat Med 2015;21:1350–6.

Karki L. Review of FDA law related to pharmaceuticals: the hatch-waxman act, regulatory amendments and implications for drug patent enforcement. J Pat Off Soc 2005;87:602–20.

Postow MA, Callahan MK, Wolchok JD. immune checkpoint blockade in cancer therapy. J Clin Oncol 2015;33:1974–82.

Dunn GP, Koebel CM, Schreiber RD. Interferons, immunity and cancer immunoediting. Nat Rev Immunol 2006;6:836–48.

Johnstone TC, Park GY, Lippard SJ. Understanding and improving platinum anticancer drugs-phenanthriplatin. Anticancer Res 2014;34:471–6.

Oun R, Moussa YE, Wheate NJ. The side effects of platinum-based chemotherapy drugs: a review for chemists. Dalton Trans 2018;47:6645–53.

Bhavani P, Prasada Rao K, Mohan S. Novel validated reversed-phase high-performance liquid chromatography method for determination of glucosamine, diacerein, and methyl sulfonyl methane in micro-sample rat plasma and its application to pharmacokinetic and dissolution studies. Asian J Pharm Clin Res 2020;13:50-63.

Mukta D Naykode, Durgacharan A Bhagwat, Swapnil D Jadhav, Harinath N. Analytical and bioanalytical method for quantification of pure azilsartan, not its salt by RP-HPLC. Res J Pharm Tech 2017;10:708-14.

Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita MC. Determination of calcipotriene in calcipotriene cream 0.05% w/w by RP-HPLC method development and validation. Res J Pharm Tech 2011;4:1219-23.

Malathi S, Arunadevi N. Development and validation of stability-indicating simultaneous estimation of metformin and alogliptin in tablets by high-performance thin-layer chromatography. Int J Pharm Pharm Sci 2020;12:68-73.

Manoranjani M. A study of method development, validation and forced degradation for simultaneous quantification of cisplatin and fluorouracil in bulk and pharmaceutical dosage form by RP-HPLC. J Pharm Sci Rev 2021;13:155-61.

Prasada Rao PTSRK. A study of method development and validation for simultaneous estimation of pemetrexed and cisplatin using RP-HPLC. J Pharm Sci Rev 2021;13:143-8.

Satyadev TNVSS. A new selective separation method development and validation of cabozantinib and nivolumab using HPLC. J Pharm Sci Rev 2021;13:188-92.

David Raju M. Development and validation of HPLC method for the determination of lasmiditan drug in bulk and tablet dosage form. J Pharm Sci Rev 2021;13:170-3.

Shanmugasundaram P, Kamarapu SK. RP-HPLC method for the simultaneous estimation and validation of amlodipine besylate and atenolol in bulk and tablet dosage form in biorelevant dissolution medium (Fassif). Res J Pharm Tech 2017;10:3379-85.

International conference on harmonization. ICH harmonized tripartite guideline. Validation of analytical procedures: Text and methodology Q2(R1); 2005.

Syed Rafi, Kantipudi Rambabu. Stability indicating validated HPLC method for the determination of aceclofenac and misoprostol in bulk and pharmaceutical formulation. Int J Res Pharm Sci 2020;11:7848-53.

Swati K, Abhishek P, Sushank S, Bothiraja C, Atmaram P. High-performance liquid chromatography for the simultaneous estimation of cefoperazone and sulbactam in rat plasma and its importance in therapeutic drug monitoring. Int J Pharm Pharm Sci 2020;12:92-7.

Rajakumari R, Sreenivasa Rao S. Stress degradation studies and development of a validated RP-HPLC method for determination of tiagabine in presence of its degradation products. Int J Pharm Pharm Sci 2016;8:230-6.

Charu Pandya P, Sadhana Rajput J. Development and validation of stability-indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci 2018;10:1-8.

Birva Athavia A, Zarna Dedania R. Stability indicating HPLC method for determination of vilazodone hydrochloride. Int J Curr Pharm Res 2017;9:123-9.



How to Cite




Original Article(s)