ABSTRACT

Objective: Development of an accurate, sensitive, precise, robust, economical and quick isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method complying quality by design (QbD) and as per ICH guidelines for the analysis as well as quantification of Pazopanib in bulk and formulation. Method: The estimation of the Pazopanib with Dasatinib as an internal standard in bulk and pharmaceutical dosage forms by quality by designs, multicriteria decision-making approach. Chromatographic separations were carried out using Phenomenex® Gemini C18 analytical column (150mm×4.6mm i.d., 5?m) and the mobile phase composed of potassium di-hydrogen ortho-phosphate (pH5) and acetonitrile at the ratio of 40:60% v/v with a flow rate of 1.2ml/min. the elutes were analyzed using PDA-UV detector at a wavelength of 290nm. The proposed method was developed and validated anticancer drug “Pazopanib” in pure form as well as pharmaceutical formulation. The method was optimized by utilizing Derringer’s desirability functions. Result: In the present study, the chromatograms of Pazopanib showed a good resolution with a retention time of 2.19min. Pazopanib showed an excellent linearity with 0.998 of correlation coefficient. The detection (LOD) and quantification limits were 10.47ng/mland 31.74ng/ml, respectively. Conclusion: Thus the newly developed and validated method can be conveniently used for the quantification of Pazopanib in bulk and formulation. Keywords: Dasatinib, Pazopanib, Quality by Design, RP-HPLC, Response Surface Methodology, Tyrosine kinase inhibitors
Publication date: 01/08/21

https://ijbpas.com/pdf/2021/August/MS_IJBPAS_2021_5516.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.8.5516