APPLICATION OF QbD APPROACH FOR ROBUST ANALYTICAL METHOD DEVELOPMENT OF SUNITINIB MALATE BY UHPLC
AbstractObjective: Sunitinib malate is an oral, potent multi-targeted TKI that displays antitumor and anti-angiogenic actions. The core focus of the present research work is to establish an innovative QbD-based analytical method for the estimation of Sunitinib malate in solid dosage form by ultra-high performance liquid chromatography (UHPLC). Materials and Methods: The change in independent variables, wavelength, flow rate and Acetonitrile concentration with response to retention time, area and tailing factor were studied using Box-Behnken design. Chromatographic separation was accomplished by using XBridge shield RP18 (50mm x 3mm, 2.5μm) column, flow rate was adjusted to 0.7mL/min. at a temperature of 25ºC. The detection was carried out at 388nm with a run time of 5 min. Results and Discussion: The retention time of Sunitinib malate was found to be 2.391 min. The method is robust, accurate and precise, as depicted by the statistical data of analysis. The correlation coefficient was found to be 0.999. The solution was found to be stable for 24 hours at 250C. Hence the current research work was found to be economical and rapid and can be used for routine laboratory analysis for quality control.
Article Information
21
1351-1359
851 KB
56
English
IJPSR
M. Sunilkumar, S. B. Haritha, P. Naresh, V. Chandran and Bharani Pandilla *
Department of Pharmaceutical Analysis, C. L. Baid Metha college of Pharmacy, Thoraipakkam, Chennai, Tamil Nadu, India.
bharaniashok@gmail.com
19 December 2024
31 December 2024
05 January 2025
10.13040/IJPSR.0975-8232.16(5).1351-59
01 May 2025
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