A Novel Stability Indicating Reversed Phase Ultra Performance Liquid Chromatography Method for Estimation of Asciminib its Bulk and Tablet Formulation
Keywords: Asciminib, Sensitivity, Stability indicating, WATERS ultra-performance liquid chromatography, Trifluoro acetic acid.
AbstractThe key objective of the proposed study was to creat and validate an economical, perceptive, specific, reliable and simple reversed phase ultra-performance liquid chromatography (RP-UPLC) method with better response was anticipated for the investigation of asciminib bulk powder and its tablet form. UPLC system (WATERS, Model-2695) connected with PDA (Model-2996) detector was opted to made the present method. To separate asciminib proficiently, method conditions such as C18 column (50 x 4.6 mm, 1.7 m), mobile system of trifluoro aceticacid (TFA) in water (0.1%) and acetonitrile in 75:25 v/v, 0.3 mL/min flow rate and 260 nm wavelength were used as optimized chromatographic conditions. The anticipated method was validated by the ICH specifications. The retention time of asciminib was noticed at 0.925 minute with good efficiency, respectively. Linearity was noticed for concentrations ranging fom 5 to 30 μg/mL of asciminib with R2 value of 0.999. The %RSD of both system and method precision was assessed in the range of 0.49 to 0.86. The percentage recovery of asciminib was in the range of 100.06–100.6%. The logarithm of the odds (LoD) and limit of quantitation (LoQ) of asciminib determined to be 0.23 and 0.69 μg/mL correspondingly. The results confirmed that the projected technique was economical, simple, responsive and precise. Exploration of asciminib under various FD environments confirms the stability representing the nature of the stated method. The proposed UPLC method is extremely valuable in the separation and estimation of asciminib.
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