NGHIÊN CỨU ĐỊNH LƯỢNG NGUYÊN LIỆU PAZOPANIB HYDROCLORID BẰNG PHƯƠNG PHÁP SẮC KÍ LỎNG HIỆU NĂNG CAO

Abstract

  Background: Pazopanib hydrochloride is a widely used drug in the treatment of renal cell carcinoma and soft tissue sarcoma, but it lacks a dedicated monograph in reputable pharmacopoeias. In Vietnam, some studies have been conducted on the synthesis of pazopanib hydrochloride, but no research has been carried out on the quantitative analysis. Therefore, there is a need to develop a reliable quantification method for pazopanib hydrochloride using highperformance liquid chromatography (HPLC) to establish quality standards and evaluate the stability of the synthesized product. Objectives: To develop and validate a quantitative method for pazopanib hydrochloride using high-performance liquid chromatography. Materials and Methods: The sample used was pazopanib hydrochloride synthesized at Hanoi University of Pharmacy. The reference standard was pazopanib hydrochloride from TRC, Canada. Equipment used included a Waters Acquity Arc HPLC system (USA), analytical balance, and other standard laboratory apparatus. Method: The chromatographic conditions were selected based on previously published methods. The blank sample was a mixture of acetonitrile and water (50:50), with the test and reference samples prepared at a concentration of 500 µg/mL and filtered through a 0.45 µm membrane filter. Method validation was performed according to ICH guidelines, evaluating system suitability, specificity, accuracy, linearity, precision, and robustness. Results: The chosen chromatographic conditions included a C18 column (250 mm x 4.6 mm, 5 µm), mobile phase of pH 8 buffer and acetonitrile (55:45), flow rate of 1.0 mL/min, column temperature at 30 °C, DAD detector at 269 nm, and an injection volume of 10 µL. The method showed satisfactory accuracy (recovery from 98.09 % to 98.95 %), good precision (RSD = 0.09 %), and a strong linear correlation (r = 0.998) within the concentration range of 250-750 µg/mL.Conclusion: A reliable HPLC method for the quantification of pazopanib hydrochloride has been successfully developed and validated.