A STUDY OF METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION FOR SIMULTANEOUS QUANTIFICATION OF CABOZANTINIB AND NIVOLUMAB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2019, Vol 12, Issue 2
Abstract
Objective: The present paper describes a simple, accurate, and precise reversed-phase high-performance liquid chromatography (HPLC) method for rapid and simultaneous quantification of cabozantinib (CZT) and nivolumab (NVM) in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Luna C18 (150 mm×4.6 mm, 3.5 μm). Mobile phase contained a mixture of 0.1% orthophosphoric acid and acetonitrile in the ratio of 50:50 v/v, flow rate 1.0 ml/min, and ultraviolet detection at 222 nm. Results: The proposed method shows a good linearity in the concentration range of 20–300 μg/ml for CZT and 5–75 μg/ml for NVM under optimized conditions. Precision and recovery study results are in between 98 and 102%. In the entire robustness conditions, percentage relative standard deviation is <2.0%. Degradation has minimum effect in stress condition and solutions are stable up to 24 h. Conclusion: This method is validated for different parameters such as precision, linearity, accuracy, limit of detection (LOD), limit of quantification (LOQ), ruggedness, robustness, and forced degradation study were determined according to the International Conference of Harmonization (ICH) Q2B guidelines. All the parameters of validation were found to be within the acceptance range of ICH guidelines. Since there is no HPLC method reported in the literature for the estimation of CZT and NVM in pharmaceutical dosage forms, there is a need to develop quantitative methods under different conditions to achieve improvement in sensitivity, selectivity, etc. The author declares the interest to develop a validation and forced degradation for simultaneous quantification of CZT and NVM.
Authors and Affiliations
GOPINATH K, YANADIRAO M, PAVANI Y, SUBBA RAO M
Keywords
Related Articles
- EP ID EP608742
- DOI 10.22159/ajpcr.2019.v12i2.29013
- Views 133
- Downloads 0
IMMUNOHISTOCHEMICAL EXPRESSION OF THE PROMISING THERAPEUTIC TARGET (HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2/NEU) IN IRAQI PATIENTS WITH MEDULLOBLASTOMA
Objectives: With the advent of ongoing novel modalities toward the treatment of human epidermal growth factor receptor 2 (HER2)/NEU - positive malignancies, the serious side effects of chemoradiotherapy have been minimiz...
BALANITES MAUGHAMII SPRAGUE (ZYGOPHYLLACEAE) IN TROPICAL AFRICA: A SYNTHESIS AND REVIEW OF ITS CHEMISTRY, PHARMACOLOGY, AND MEDICINAL POTENTIAL
Balanites maughamii is an important medicinal plant species in Southern Africa. This study is aimed at providing a critical review of the biological activities, phytochemistry, and medicinal uses of B. maughamii. Documen...
PLASMA TRACE ELEMENT STATUS IN BETA-THALASSEMIA TRAIT PATIENTS
Objective: The study aims to evaluate the plasma trace element status in beta-thalassemia trait (BTT) patients and demonstrate the correlation between trace elements and hemoglobin (Hb)-A1, HbA2, and HbF.Methods: The stu...
EVALUATION OF EFFECT OF AQUEOUS EXTRACT OF ZINGIBER OFFICINALE ROSCOE (GINGER) ON ACUTE AND CHRONIC INFLAMMATION IN ADULT ALBINO RATS
 Objective: Zingiber officinale (ZO) Roscoe (Ginger) is known to have many medicinal properties. The present study was carried out to evaluate theanti-inflammatory activity of aqueous extract of ginger in adult albino r...
EFFECT OF ULTRA-DILUTED HISTAMINE ON HYPOXIC CHICK LUNG TISSUE INFLAMMATORY CHANGES
Objectives: Since its discovery, the role of histamine in inflammation is controversial; thus, according to some authority, it is mainly pro-inflammatory, and according to others, it is anti-inflammatory in nature. In th...