ANALYTICAL METHOD AND VALIDATION FOR THE ESTIMATION OF ANTI- DIABETIC AGENT SEMAGLUTIDE IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

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Dr. Subhas Sahoo, Dr.D.Varun2, S. Saritha, Dr.S.Srinivasa Rao

ABSTRACT: We have developed and validated an easy-to-use RP-HPLC method for quantifying Semaglutide in both bulk and commercially available pharmaceutical dosage forms. A 40:60 v/v blend of methanol and phosphate buffer (0.02M, pH 3.6) served as the mobile phase for the chromatographic runs. Using the isocratic mode, the separation was achieved on a 4.6mm × 250mm Inertsil C18 ODS column with a particle size of 5µm.A UV detector at 246 nm caught the drug signal, which was clearly separated. Semaglutide was shown to have a retention time of 5.493 minutes. For Semaglutide values between 6 and 14μg/ml, the method followed a linear pattern. System appropriateness, specificity, accuracy, and robustness were evaluated using ICH standards, which the technique has successfully passed. The 0.487 g/ml LOD and the 1.477 εg/ml LOQ for Semaglutide were determined, respectively.

Accuracy, precision, robustness, RP-HPLC, Semaglutide.