Method Development and Quantification of Cabozantinib in Human Plasma by Using LC-MS/MS
Main Article Content
Abstract
The main aim of the research was to develop a fast and highly sensitive bioanalytical LC-MS/MS technique for the quantitation of Cabozantinib in human plasma. Chromatography has achieved on a Synergi polar column (75 mm x 4.6 mm ID, 4 μm) and mobile phase containing a mixture of 10 mM Ammonium acetate buffer with 0.2% formic acid were mixed with HPLC grade Acetonitrile in the proportion of 30:70, v/v. Chromatographic peaks were resolved with 0.40 ml/min flow rate. Drug was extracted by simple Protein Precipitation method. The precursor to product ion transitions is m/z 502.27 to 323.07 for Cabozantinib and m/z 231.25 to 185.17 for Naproxen (Internal standard) The retention time of Cabozantinib and Naproxen (Internal standard) was found to be 0.95 min and 1.50 min respectively Calibration curve of Cabozantinib was linear over 5-1000 ng/ml concentration range with a regression coefficient (r2) value of>0.99. The % RSD values were less than 6.5% for inter-day and intra-day precision and accuracy. The method has excellent recovery and the percentage recovery values of lower quality control (LQC), median quality control (MQC) and higher quality control (HQC) samples were101.02 ,98.79 and 101.24 respectively. The drug was stable for more time at variable stability conditions and method was successfully applicable to the regular analysis of Cabozantinib in biological matrices.
Article Details
References
European Pharmacopoeia. European Pharmacopoeia. 10 edn. 2020 https://www.edqm.eu/en/european_ pharmacopoeia_10th_edition
Kurzrock R, Sherman SI, Ball DW, Forastiere AA, Cohen RB, Mehra R, et al. Activity of XL184 (Cabozantinib), an oral tyrosine kinase inhibitor, in patients with medullary thyroid cancer. J Clin Oncol 2011;29:2660-6.
Yakes FM, Chen J, Tan J, Yamaguchi K, Shi Y, Yu P, et al. Cabozantinib (XL184), a novel MET and VEGFR2 inhibitor, simultaneously suppresses metastasis, angiogenesis, and tumor growth. Mol Cancer Ther 2011;10:2298-308.
Zhang J, Yang PL, Gray NS. Targeting cancer with small molecule kinase inhibitors. Nat Rev Cancer 2009;9:28-39.
Arora A, Scholar EM. Role of tyrosine kinase inhibitors in cancer therapy. J Pharmacol Exp Ther 2005;315:971-9.
Walker JG, Ahern MJ, Coleman M, Weedon H, Papangelis V, Beroukas D, et al. Changes in synovial tissue jak-STAT expression in rheumatoid arthritis in response to successful DMARD treatment. Ann Rheum Dis 2006;65:1558-64
Dionigi G, Bianchi V, Rovera F, et al. Medullary thyroid carcinoma: surgical treatment advances. Expert Rev Anticancer Ther. 2007, 7 (6): 877–85.
Nuli, Mohana Vamsi, Darna Bhikshapathi, Anil Kumar Garige, Vijitha Chandupatla, Surya Lakshmi Sunkara, and Parul Grover. "Ultra‐high‐performance liquid chromatography method development for the quantification of Molnupiravir and its process‐related impurities using Box‐Behnken experimental design." Separation Science Plus: 2300213.
Reddy, Y. Padmanabha, N. Mohana Vamsi, Manish Shrivas, Avirneni Srinivas, and M. Ramakumar. "Simultaneous Determination of Niacin and Lovastatin in Tablet Dosage Form by Reverse Phase HPLC." Asian Journal of Chemistry 23, no. 11 (2011): 5123.
Reddy, Y. Padmanabha, N. Mohana Vamsi, Manish Shrivas, and MV Sunil Kumar. "Enantioselective Separation and Determination of Formoterol in Bulk Drugs and Formulations by High Performance Liquid Chromatography." Asian Journal of Chemistry 23, no. 11 (2011): 4997.
Reddy, Y. Padmanabha, N. Mohana Vamsi, Manish Shrivas, and MV Sunil Kumar. "Enantioselective Separation and Determination of Pirbuterol in Bulk Drugs and Formulations by HPLC." Asian Journal of Chemistry 23, no. 8 (2011): 3509.
N. Mohana Vamsi et al. method development and validation of UV- visible spectrophotometric method for the determination of sofosbuvir and ledipasvir in pharmaceutical API and its formulation. J Pharm Res 2018;7(6):88-65.
Tallam, A. K., S. Alapati, and M. V. Nuli. “A Review of Analytical Techniques for Determination of Metformin: Present and Perspectives”. International Journal of Health Care and Biological Sciences, Vol. 4, no. 1, Feb. 2023, pp. 18-24,
Tallam, A. K., Alapati , S., & Nuli, M. V. (2023). A review on bioanalytical method development and validation of anticancer drugs by using lc/ms/ms and its applications on routine analysis. Journal of Integral Sciences, 6(1), 4-19.
K. Tallam, A. Sahithi, and M. V. Nuli, “Evaluation of antibacterial property of anthyocyanin extracted from brassica oleracea against gram positive and gram negative bacteria by using erythromycin as a standard drug.”, Int J Indig Herb Drug, vol. 8, no. 1, pp. 1-6, Feb. 2023.
Tallam, A. K., A. Sahithi, and M. V. Nuli. “A Review on Phytosomes As Innovative Delivery Systems for Phytochemicals”. International Journal of Pharmacognosy and Chemistry, Vol. 4, no. 1, Feb. 2023, pp. 1-8, doi:10.46796/ijpc.v4i1.416
Tallam, A. K., Alapati , S., & Nuli , M. V. (2023). RP-HPLC method for analytical method development and validation of multi-kinase inhibitor. Journal of Integral Sciences, 6(1), 20-26. https://doi.org/10.37022/jis.v6i1.52.
Tallam, A. K., Sahithi, A., & Nuli, M. V. (2023). A review on different kinds of analytical methods are performed for the analysis of food preservatives in food. Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 8(1), 1-10. https://doi.org/10.37022/jiaps.v8i1.414
Nuli, M. V., and V. K. Rekulapally. “Overall Review on Analytical Method Development and Validation of Dasatinib”. International Journal of Pharmacognosy and Chemistry, Vol. 4, no. 1, Mar. 2023, pp. 27-34, doi:10.46796/ijpc.v4i1.432.
Nuli, M. V. “A Review on Analytical Method Development and Validation of Erlotinib”. International Journal of Health Care and Biological Sciences, Vol. 4, no. 1, Mar. 2023, pp. 47-53, doi:10.46795/ijhcbs. v4i1.433.
Nuli, M. V. (2023). Overall Review On Analytical Method Development and Validation Of Cabozantinib. International Journal of Current Innovations in Advanced Research, 6(1), 30–35. https://doi.org/10.47957/ijciar.v6i1.147.
Mohana Vamsi N, Venkata sunil kumar M, Kodandaram N, Padmanabha Reddy Y. Evaluation of Anti-inflammatory activity of Acalypha indica. The Indian pharmacist. 2008;7(75):89-91.
Nelson VK, Nuli MV, Mastanaiah J, Saleem T. S. M, Birudala G, Jamous YF, Alshargi O, Kotha KK, Sudhan HH, Mani RR, Muthumanickam A, Niranjan D, Jain NK, Agrawal A, Jadon AS, Mayasa V, Jha NK, Kolesarova A, Slama P and Roychoudhury S (2023) Reactive oxygen species mediated apoptotic death of colon cancer cells: therapeutic potential of plant derived alkaloids. Front. Endocrinol. 14:1201198. doi: 10.3389/fendo.2023.1201198
Jha, Niraj Kumar, Vinod Kumar Nelson, Mohana Vamsi Nuli, Sandeep Kanna, Reema M. Gahtani, Umme Hani, Arun Kumar Singh et al. "Unveiling the impact of Aging on BBB and Alzheimer's disease: Factors and Therapeutic implications." Ageing Research Reviews (2024): 102224.
Papinaboina Venkata Rao, Chinnakadoori Sanjeeva Reddy, Ravi Kumar Marram, Dantu Durga Rao, Simultaneous Determination of Omeprazole and Domperidone in Capsules and in Vitro Dissolution Studies by Using Stability Indicating UPLC, Journal of liquid chromatography & related technologies, 2012, 35 (16), 2322-2332.
Niroja Vadagam, Sharath Babu Haridasyam, Muvvala Venkatanarayana, Narasimha S. Lakka, Sanjeeva R. Chinnakadoori, 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, 35(12), 952-965.
Niroja Vadagam, Sharath Babu Haridasyam, Muvvala Venkatanarayana, Narasimha S Lakka, Sanjeeva R Chinnakadoori, Separation and quantitation of valacyclovir enantiomers using stability-indicating chiral liquid chromatography method with a chiral stationary phase of amylose tris-(3,5-dimethylphenylcarbamate), Separation Science Plus, 2023, 6(12), 2300145.
Narasimha S Lakka, Chandrasekar Kuppan, Niroja Vadagam, Poornima Ravinathan, Kalyani Chepuri, Sanjeeva R Chinnakadoori, Molecular docking, in-vitro anticancer evaluation and ADME profiling of 7-Oxo Midostaurin, Journal of Molecular Structure, 2023, 1293, 136159.
Konatham Teja Kumar Reddy, & M. Akiful Haque. (2022). Develop and validate a highly sensitive method for the estimation of Molnupiravir in rat plasma by high-performance liquid chromatography-tandem mass spectroscopy and its application to pharmacokinetic studies. Journal of Pharmaceutical Negative Results, 28–34. https://doi.org/10.47750/pnr.2022.13.S01.0
Konatham Teja Kumar Reddy, Penke Vijaya Babu, Rajinikanth Sagapola, & Peta Sudhakar. (2022). A REVIEW OF ARTIFICIAL INTELLIGENCE IN TREATMENT OF COVID-19. Journal of Pharmaceutical Negative Results, 254–264. https://doi.org/10.47750/pnr.2022.13.S01.31
Konatham Teja Kumar Reddy, Kumaraswamy Gandla, Penke Vijaya Babu, M Vinay Kumar Chakravarthy, Pavuluri Chandrasekhar, & Rajinikanth Sagapola. (2022). A Critical Review On Bioanalytical Method Development And Validation Of Few Oncology Drugs By Using Lc-Ms-Ms. Journal of Pharmaceutical Negative Results, 16–27. https://doi.org/10.47750/pnr.2022.13.S01.03
Reddy, K. T. K., & Haque, M. A. (2022). Bioanalytical method development and validation of atrasentan in human plasma using verapamil as internal standard by liquid chromatography coupled with tandem mass spectrometry. International Journal of Health Sciences, 6(S8), 625–638. https://doi.org/10.53730/ijhs.v6nS8.10470
Konatham Teja Kumar Reddy et.al High Performance Liquid Chromatography for The Simultaneous Estimation of Anti-Ulcer Drugs in Pharmaceutical Dosage Form, journal of Positive School Psychology, Vol. 6, No. 9, 4524-452
Reddy KTK, Haque MA. Development and Validation of a High Throughput Lc-Ms/MS Method for Quantitation of Ipilimumab in Human Plasma. International Journal of Pharmaceutical Quality Assurance. 2022;13(3):303-307
Teja Kumar Reddy Konatham, M. Anuradha (2020), 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, 9(3): 36-44
Teja Kumar Reddy Konatham, Satyanarayana Reddy K., Anuradha Manipogo, a Review on viruses that originated from china; Sars, mers and covid-19 World Journal of Pharmaceutical Research, Vol 9, Issue 5, 2020, 2010-2015.
Teja Kumar Reddy Konatham et al, A Systematic Review on Method Development and Validation of Few Antiviral Drugs by Using RP-HPLC. Ijppr.Human, 2021; Vol. 21 (3): 651-661.
Konatham Teja Kumar Reddy and Kumaraswamy Gandla. Novel Vesicular Drug Delivery Systems Proniosomes. Pharm Res 2022, 6(3): 000272.
Niroja Vadagam, Sharath Babu Haridasyam, Muvvala Venkatanarayana, Narasimha S Lakka, Sanjeeva R Chinnakadoori, Separation and simultaneous estimation of enantiomers and Diastereomers of muscarinic receptor antagonist Solifenacin using stability-indicating Normal-phase HPLC technique with chiral stationary phase amylose tris-(3,5-dimethylphenylcarbamate), Chirality, 2024, 36(2), e23632.
Mohan Pasham, Sharath Babu Haridasyam, Niroja Vadagam, NVVD Praveen Boppy, Sanjeeva R Chinnakadoori, Narasimha S Lakka, Separation and quantification of organic-related impurities of beta-adrenergic receptor blocking agent propranolol in pharmaceutical solid dosage forms: Impurity profiling using stability-indicating HPLC method, 2024, 7(1), 2300159.
N. V. V. D. Praveen Boppy, Sharath Babu Haridasyam, Niroja Vadagam, Muvvala Venkatanarayana, Sanjeeva R. Chinnakadoori, Narasimha S. Lakka, Separation and quantification of organic-related impurities of anti-histamine drug hydroxyzine in pharmaceutical dosage forms using stability-indicating high-performance liquid chromatography, liquid chromatography-mass spectrometry, and high-resolution mass spectrometry techniques, Separation Science Plus, 2024, 2300157.
Teja Kumar Reddy Konatham, M. Anuradha (2020), 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, 9(3): 36-44