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Rp HPLC Method Development for Pazopanib in mixture and tablet Form

Author: Godge R. K. and Ghorpade R. S.

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Abstract

Analytical method development involves screening various column and eluent conditions, method optimization includes iterative testing of various separation conditions of the HPLC method and is performed to achieve the best possible resolution, speed, and reproducibility, robustness testing and method validation. Pazopanib is a class of drugs called kinase inhibitors with potent antineoplastic effects and is used in the treatment of kidney and soft tissue sarcomas. This work includes the development of a simple, accurate, precise and reproducible liquid chromatography (RP HPLC) method for the determination of pazopanib in tablet dosage. Isocratic elution was performed at a flow rate of 1.0 mL/min on a Kromasil C18 column (250 mm × 4.6 mm, 5 μm) at 25 °C. The mobile phase was methanol: 0.025% TFA in water (60:40) v/v. The UV detection wavelength is 273 nm and the injection volume is 20 µL. Pazopanib has a retention time of approximately 2.83 minutes. According to ICH guidelines, the process has been validated for various parameters such as suitability, efficiency, recovery and robustness. The validated RP HPLC method is specific, precise, and accurate, and has been successfully used to identify pazopanib and its commercial samples.

Keywords

HPLC, pazopanib, ICH guideline, method development, validation

Conclusion

The study described a new RP HPLC method that uses a simple phase to quantitatively measure pazopanib content compared to the reported. The method provides good resolution of both compounds with a short measurement time (<10 minutes). The method is simple, precise, accurate and straightforward. Recovery data showed that the method was not affected by the excipients used in the formulation. Therefore, this method can be used for routine analysis of pazopanib in dosage form.

References

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How to cite this article

Godge R. K. and Ghorpade R. S. (2023). Rp HPLC Method Development for Pazopanib in mixture and tablet Form. Biological Forum – An International Journal, 15(4): 475-478.