STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF VIMSELTINIB BY USING HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM.

Shaileshkumar Bhingaradiya; Venkata Lakshmanan Sagar Dantinapalli; Selvaraja Elumalai

doi:10.47957/ijpda.v14i1.688

Authors

Shaileshkumar Bhingaradiya Associate Director Quality Control, Granules Pharmaceutical Inc., Chantilly, VA-20151, USA.
Venkata Lakshmanan Sagar Dantinapalli Department of Chemistry, Raffles University, Neemrana, Alwar, Rajasthan 301705, India
Selvaraja Elumalai Department of Chemistry, Raffles University, Neemrana, Alwar, Rajasthan 301705, India

DOI:

https://doi.org/10.47957/ijpda.v14i1.688

Keywords:

HPLC, Vimseltinib, Formic acid, Acetonitrile, ICH guidelines

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Vimseltinib in bulk and pharmaceutical dosage form. Chromatographic separation of Vimseltinib was achieved on Waters Alliance-e2695_,by using Waters Agilent Eclipse XDB (150x4.6 mm, 3.5µm) column and the mobile phase containing Acetonitrile and 0.1% Formic acid in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 221nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Vimseltinib were NLT 2000 and should not more than 2, respectively. % Relative standard deviation of peak areas of all measurements is always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be a simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Vimseltinib.

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References

Caldwell TM, Ahn YM, Bulfer SL, Leary CB, Hood MM, Lu WP, Vogeti L, Vogeti S, Kaufman MD, Wise SC, Le Bourdonnec B, Smith BD, Flynn DL: Discovery of vimseltinib (DCC-3014), a highly selective CSF1R switch-control kinase inhibitor, in clinical development for the treatment of Tenosynovial Giant Cell Tumor (TGCT). Bioorg Med Chem Lett. 2022 Oct 15;74:128928. doi: 10.1016/j.bmcl.2022.128928. Epub 2022 Aug 10. [Article]

Smith BD, Kaufman MD, Wise SC, Ahn YM, Caldwell TM, Leary CB, Lu WP, Tan G, Vogeti L, Vogeti S, Wilky BA, Davis LE, Sharma M, Ruiz-Soto R, Flynn DL: Vimseltinib: A Precision CSF1R Therapy for Tenosynovial Giant Cell Tumors and Diseases Promoted by Macrophages. Mol Cancer Ther. 2021 Nov;20(11):2098-2109. doi: 10.1158/1535-7163.MCT-21-0361. Epub 2021 Aug 25. [Article]

N.R. Soundaryashree, R.S. Chandan, V.R. Singamaneni, H.R. Nagidi, G. Patel, N. Vidiyala, H. Sumanya, G.Dharmamoorthy. Development and Validation of RP-HPLC Method for Quantification of Bamifylline in PharmaceuticalFormulations using Analytical Quality by Design (AQbD) Principles. Adv. J. Chem. A, 2025, 8(12), 2076-2097.

Yelampalli SR, Gandla K, Reddy KTK, Ibrahim AE, El Deeb S. Determination of Sodium, Potassium, and Magnesium as Sulfate Salts in Oral Preparations Using Ion Chromatography and Conductivity Detection. Separations [Internet]. 2023 Feb 1;10(2):99. Available from: https://www.mdpi.com/2297-8739/10/2/99

Konatham TK. A Systematic Review on Method Development and Validation of Few Antiviral Drugs by Using RP-HPLC. Ijppr. Human. 2021;21(3):651-61.

Niroja Vadagam, Sharath Babu Haridasyam, M. Venkatanarayana, Narasimha Swamy Lakka, Chinnakadoori SR. Separation and quantitative estimation of stereo?selective enantiomers of montelukast in pharmaceutical drug substance and tablets dosage forms by using stability?indicating normal phase?HPLC method. Chirality. 2023 Jul 17;

Konatham TK, Anuradha M, Narmada A. a stability indicating method development and validation of Telmisartan and Nifedipine in pure form using RP-HPLC. International Journal of Pharmaceutical, Biological and Chemical Sciences. 2020;9(3):36-44.

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.

Pokuri Chiranjeevi, Rao S, V. Rithvika, Anoop Bodapati, HariHaran K, Kanamaneni Chinna Kondanna, et al. Current Advances in Pharmaceutical Analytical Methods for the Aminoglycoside Antibiotic: Gentamicin. International Journal of Advanced Science and Engineering. 2025 Sep 27;12(1):5335–56.

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.

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

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.

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.

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.

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.