A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Belinostat in pharmaceutical dosage form. The column used was ALTIMA C18, 150 x 4.6 mm, 5 with mobile phase containing Buffer and Acetonitrile were taken in the ratio of 40:60 the flow rate was 1.0 mL/ min and eluent was monitored at 266nm. The retention time of Belinostat was 2.320 min. The linearity of the drug was designed at a range for which correlation coefficient was 0.999. The proposed method was validated and successfully applied to the estimation of Belinostat in formulations. Forced degradation studies were conducted to identify reactions which may occur to degrade a processed product.
Objective:The present study is to develop a simple, specific, and validated reverse-phase high-performance liquid chromatography (HPLC) method for the determination of imatinib mesylate and its dimer impurity in pharmaceutical dosage form.
Methods:A HPLC instrument incorporated with column HiQ Sil C18 (250 mm × 4.6 mm, 5 μm), mobile phase as methanol and acetate buffer pH 3.5 in the ratio of 80:20 v/v was used for the determination of the imatinib mesylate and its dimer impurity. The detection wavelength was set at 273 nm. The flow rate of the mobile phase was 1.0 mL/min.
Results:The retention time for imatinib mesylate was 8.060, and for dimer impurity, it was 11.398. The calibration plot was linear (R 2 =0.9971) and the % mean recoveries for imatinib mesylate were in the range of 99.83-101.57, and for dimer impurity, it was in the range of 98.16-99.18. The limit of detection concentration was found to be 0.570 μg/ml for imatinib mesylate and 0.033 μg/ml dimer impurity and limit of quantification concentration was 1.728 μg/ml for imatinib mesylate and 0.099 μg/ml dimer impurity.
Conclusion:The projected method was validated and successfully functional for the estimation of imatinib mesylate and dimer impurity in formulations. It can be adopted apparently for routine quality control and research tests.
This research objective is for the development of a specific and simple method to trace Semaglutide presence in active pharmaceutical ingredient and pharmaceutical dosages. As part of a study on Semaglutide drug, solvents of HPLC grade waters HPLC instrument (Empower software) with PDA detector, ultrasonicator (Make: Labman) and pH meter (Make: Adwa) are used. The Method was optimized with mobile phase with a composition of buffer and solvent were of 60:40%v/v, flow maintained was 1.0ml/min, the injection volume of 10µl, run time was 5min. All separations were performed with PDA detector and column used was Discovery C18 150 x 4.6mm, 5m. Results for the developed method are accurate and specific. The detection wavelength was 292 nm, the retention time for Semaglutide was 2.689min, linearity resulted with r2= 0.9998, % RSD for precision was 1.0; %mean recovery for accuracy was in the range of 99.73 to 100.29. This study report is for industrial application for determining Semaglutide presence in pharmaceutical ingredient and dosages.
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