SIMULTANEOUS METHOD VALIDATION FOR THE ESTIMATION OF NIVOLUMAB AND CABOZANTINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

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Autori principali: Dr. Sreenivasa Charan Archakam, Dr. Keerthisikha Palur, Bukke Nagalakshmi*, Dr. Ranganayakulu Diviti
Natura: Recurso digital
Lingua:inglese
Pubblicazione: Zenodo 2026
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author Dr. Sreenivasa Charan Archakam
Dr. Keerthisikha Palur
Bukke Nagalakshmi*
Dr. Ranganayakulu Diviti
author_facet Dr. Sreenivasa Charan Archakam
Dr. Keerthisikha Palur
Bukke Nagalakshmi*
Dr. Ranganayakulu Diviti
contents <p class="MsoNormal"><strong><span>Aim:</span></strong><span> </span><span>The present study aimed to progress a modest, novel, and specific method for the simultaneous evaluation of Nivolumab and Cabozantinib in bulk and tablet dosage form by Reverse-phase high-performance liquid chromatography (RP-HPLC). <strong>Material and Methods:</strong></span><span> </span><span>Nivolumab and Cabozantinib pure drugs (API), Combination Nivolumab and Cabozantinib Synthetic Formulation, Distilled water, Acetonitrile, Phosphate buffer, Methanol, Potassium dihydrogen ortho phosphate buffer, Ortho-phosphoric acid. All the above chemicals and solvents are from Rankem.</span><span> </span><span>Based on the solubility of the drugs, diluent was selected, Acetonitrile and H2O in the ratio of 50:50 v/v. <strong>Results:</strong> The method exhibited excellent precision with %RSD values of 0.7 for Nivolumab and 0.9 for Cabozantinib. Recovery studies revealed the method`s accuracy with recovery rates of 100.16% for Nivolumab and 99.63% for Cabozantinib. Limits of detection(LOD) and quantification(LOQ) were determined as 0.20 µg/mL, 0.03 µg/mL for Nivolumab and 0.61µg/mL,0.08 µg/mL for Cabozantinib. The regression equations obtained for Nivolumab and Cabozantinib were y =39306x + 12173 and y =34894x +1139.7 respectively. <strong>Conclusion:</strong></span><span> </span><span>The benefit is in the ease of sample preparation and the cost-effective use of fewer chemicals and the precision and reproducibility of the experimental data are good, according to statistical analysis.</span></p>
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language eng
publishDate 2026
publisher Zenodo
record_format zenodo
spellingShingle SIMULTANEOUS METHOD VALIDATION FOR THE ESTIMATION OF NIVOLUMAB AND CABOZANTINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
Dr. Sreenivasa Charan Archakam
Dr. Keerthisikha Palur
Bukke Nagalakshmi*
Dr. Ranganayakulu Diviti
Lamivudine
Dolutegravir
RP-HPLC
Tablet dosage form
Validation
Quality control
LOD
LOQ
Recovery
%RSD
<p class="MsoNormal"><strong><span>Aim:</span></strong><span> </span><span>The present study aimed to progress a modest, novel, and specific method for the simultaneous evaluation of Nivolumab and Cabozantinib in bulk and tablet dosage form by Reverse-phase high-performance liquid chromatography (RP-HPLC). <strong>Material and Methods:</strong></span><span> </span><span>Nivolumab and Cabozantinib pure drugs (API), Combination Nivolumab and Cabozantinib Synthetic Formulation, Distilled water, Acetonitrile, Phosphate buffer, Methanol, Potassium dihydrogen ortho phosphate buffer, Ortho-phosphoric acid. All the above chemicals and solvents are from Rankem.</span><span> </span><span>Based on the solubility of the drugs, diluent was selected, Acetonitrile and H2O in the ratio of 50:50 v/v. <strong>Results:</strong> The method exhibited excellent precision with %RSD values of 0.7 for Nivolumab and 0.9 for Cabozantinib. Recovery studies revealed the method`s accuracy with recovery rates of 100.16% for Nivolumab and 99.63% for Cabozantinib. Limits of detection(LOD) and quantification(LOQ) were determined as 0.20 µg/mL, 0.03 µg/mL for Nivolumab and 0.61µg/mL,0.08 µg/mL for Cabozantinib. The regression equations obtained for Nivolumab and Cabozantinib were y =39306x + 12173 and y =34894x +1139.7 respectively. <strong>Conclusion:</strong></span><span> </span><span>The benefit is in the ease of sample preparation and the cost-effective use of fewer chemicals and the precision and reproducibility of the experimental data are good, according to statistical analysis.</span></p>
title SIMULTANEOUS METHOD VALIDATION FOR THE ESTIMATION OF NIVOLUMAB AND CABOZANTINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
topic Lamivudine
Dolutegravir
RP-HPLC
Tablet dosage form
Validation
Quality control
LOD
LOQ
Recovery
%RSD
url https://doi.org/10.5281/zenodo.19761594